Study supporting the
monitoring of the availability
of medical devices on the EU market
Survey results of the 20th NB survey (MDR/IVDR)
with data status 28 February 2026
(small and medium dataset)
2 July 2026
1
• This document was produced in the frame of the SC 2021 P3 03 under the DG SANTE
Framework contract (FWC SANTE/2021/OP/0002) for evaluation, impact assessment,
monitoring and other related services in relation to health and food policies.
• The information and views set out in this document are those of the author(s) and do not
necessarily reflect the official opinion of the Commission/Executive Agency. Neither the
Commission/Executive Agency nor any person acting on the Commission’s/Executive
Agency’s behalf may be held responsible for the use which may be made of the
information contained therein.
• This presentation includes data and knowledge available at the time of the publication.
The study-related dashboard contains the latest information und updates (e.g. further
insights, retrospective corrections reported by stakeholders). Data discrepancies between
this presentation and the regularly updated dashboard are therefore possible.
2
Disclaimer
https://app.powerbi.com/view?r=eyJrIjoiMmRhNTZkOTAtNTM4YS00NmE5LWExYjYtZjIzYzI5YjUwMzRiIiwidCI6ImIyNGM4YjA2LTUyMmMtNDZmZS05MDgwLTcwOTI2ZjhkZGRiMSIsImMiOjh9
3
Acknowledgements
The study team would like to sincerely thank the following institutions and people for the
support in the 20th NB survey:
• All 53 notified bodies designated under MDR and/or IVDR that participated in the survey
(100% response rate);
• The Directorate General for Health and Food Safety at the European Commission (DG
SANTE) and the European Health and Digital Executive Agency (HaDEA);
• Members of the MDCG TF on certification capacity monitoring.
1. About the study, survey and datasets
2. Survey results for medical devices
3. Survey results for in vitro diagnostic medical devices
4
Content
MD
IVD
About
Please cite as: Austrian National Public Health Institute, Areté, Civic Consulting (2026). PowerPoint presentation containing a study overview and survey results of
the 20th NB survey for the ʻStudy supporting the monitoring of availability of medical devices on the EU marketʼ. Austrian National Public Health Institute
(Gesundheit Österreich GmbH / GÖG). Commissioned by the European Commission within the EU4Health Programme (under specific contract No 2021 P3 03
with the European Health and Digital Executive Agency, implementing framework contract No SANTE/2021/OP/0002).
5
List of abbreviations (1)
Abbreviation Meaning
AIMDD Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable
medical devices
CE Conformité Européenne
DG SANTE Directorate-General for Health and Food Safety
EC European Commission
EU European Union
EURLs EU reference laboratories
FTE Full Time Equivalent
FWC Framework contract
GÖG Gesundheit Österreich GmbH / Austrian National Public Health Institute
HaDEA European Health and Digital Executive Agency
IVDs In-vitro diagnostic medical device(s)
IVDD Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices
IVDR Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 (In Vitro Diagnostic Medical Device Regulation)
LD Large dataset
6
List of abbreviations (2)
Abbreviation Meaning
MD Medium dataset
MDCG Medical Device Coordination Group
MDs Medical device(s)
MDD Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
MDR Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (Medical Device Regulation)
MFs Manufacturer(s)
NBs Notified body / bodies
QMS Quality Management System
SC Special contract
SD Small dataset
SMCS Single Market Compliance Space
SMEs Small and medium-sized enterprise(s)
TF Task Force
7
1. About the study, survey and
datasets
• Study supporting the monitoring of availability of medical devices on the EU market
• Preliminary notes
• NB survey overview
• Dashboard
• Survey timeline
• Response rate
About
• Commissioned by: The European Commission’s Directorate-General for Health and Food
Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA)
• Aim: To support monitoring and analyzing the availability of medical devices on the EU market
in the context of the implementation of medical devices and in vitro diagnostic medical devices
Regulations from the perspectives of key stakeholders
• Duration: 2 December 2022 – 1 June 2026 (42 months*)
• Study team (contact: medical.devices@goeg.at):
Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG) project lead
Areté
Civic Consulting
Supported by experts from the medical devices sector
8
Study supporting the monitoring of availability of
medical devices on the EU market
About
* Study amendment from 2 December 2025 – 1 June 2026
mailto:medical.devices@goeg.at
• Data content:
• The following slides show the results of the 20th NB survey conducted at the beginning of March 2026 with
requested data from notified bodies designated under MDR and/or IVDR until 28 February 2026.
• These survey results are also compared with previous survey data (see data sources).
• Data sources:
• Data collected between April 2023 and March 2026 by the study team
• Data collected between February 2021 and October 2022 by the European Commission
• Datasets:
• This presentation contains the results of the small and medium datasets collected in March 2026.
The small dataset is a small set of questions asked to notified bodies every two months.
Note: From April to July 2023, it was asked monthly.
The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have
been performing since their designation.
9
Preliminary notes
About
Ⓢ
10
NB survey overview
NB survey Survey period
(survey launch – survey closure)
Requested dataset* Requested data Response rate
1st NB survey 03/04/2023 - 05/05/2023 SD1 + MD1 from designation up to 31/03/2023 39 out of 39 NBs (100%)
2nd NB survey 12/05/2023 - 05/06/2023 SD2 from designation up to 30/04/2023 27 out of 39 NBs (~70%)
3rd NB survey 05/06/2023 - 19/06/2023 SD3 from designation up to 31/05/2023 22 out of 39 NBs (~56%)
4th NB survey 03/07/2023 - 28/07/2023 SD4 + MD2 from designation up to 30/06/2023 39 out of 39 NBs (100%)
5th NB survey 01/09/2023 - 06/10/2023 SD5 from designation up to 31/08/2023 40 out of 40 NBs (100%)
6th NB survey 03/11/2023 - 22/12/2023 SD6 + MD3 + LD1 from designation up to 31/10/2023 41 out of 41 NBs (100%)
7th NB survey 08/01/2024 - 05/02/2024 SD7 from designation up to 31/12/2023 45 out of 45 NBs (100%)
8th NB survey 04/03/2024 - 20/03/2024 SD8 + MD4 from designation up to 29/02/2024 45 out of 45 NBs (100%)
9th NB survey 02/05/2024 - 21/06/2024 SD9 from designation up to 30/04/2024 48 out of 48 NBs (100%)
10th NB survey 01/07/2024 - 06/08/2024 SD10 + MD5 from designation up to 30/06/2024 50 out of 50 NBs (100%)
11th NB survey 02/09/2024 - 17/10/2024 SD11 from designation up to 31/08/2024 50 out of 50 NBs (100%)
12th NB survey 06/11/2024 – 20/12/2024 SD12 + MD6 + LD2 +
TE1*
from designation up to 31/10/2024 51 out of 51 NBs (100%)
13th NB survey 21/01/2025 – 27/02/2025 SD13 + TE2** from designation up to 31/12/2024 51 out of 51 NBs (100%)
14th NB survey 03/03/2025 – 08/04/2025 SD14 + MD7 from designation up to 28/02/2025 51 out of 51 NBs (100%)
15th NB survey 05/05/2025 – 23/05/2025 SD15 from designation up to 30/04/2025 51 out of 51 NBs (100%)
16th NB survey 01/07/2025 – 02/09/2025 SD16 + MD8 + LD3 from designation up to 30/06/2025 51 out of 51 NBs (100%)
17th NB survey 01/10/2025 – 04/11/2025 SD17 from designation up to 30/08/2025 51 out of 51 NBs (100%)
18th NB survey 14/11/2025 – 15/12/2025 SD18 + MD9 from designation up to 31/10/2025 52 out of 52 NBs (100%)
19th NB survey 12/01/2026 – 10/02/2026 SD19 + LD4 from designation up to 31/12/2025 53 out of 53 NBs (100%)
20th NB survey 02/03/2026 – 31/03/2026 SD20 + MD10 from designation up to 28/02/2026 53 out of 53 NBs (100%)**
About
20th NB survey results
are presented in this
PowerPoint
presentation
Note: SD = small dataset, MD = medium dataset, LD = large dataset
* About the targeted evaluation: Evaluations conducted by the European Commission assess how well a specific policy intervention has performed (or is performing) and whether it is still relevant and justified. Evaluations are a key component of the lifecycle
of any policy intervention. For the MDR and IVDR, the Commission has a legal obligation to conduct an evaluation of the Regulations by May 2027 (Article 121 MDR/Article 111 IVDR). The Commission has decided to launch a targeted evaluation of the
Regulations in 2024. The 12th and 13th NB survey (conducted in the framework of the ‘Study supporting the monitoring of the availability of medical devices on the EU market’) were used to ask NBs questions that are relevant for the Targeted Evaluation.
** Due to a change in legal ownership of one notified body, data from previous surveys were used for the 20th NB survey
• NB survey results are presented in the study-related dashboard
• Available at: Study supporting the monitoring of availability of medical devices on the EU market -
European Commission (europa.eu)
• Instructions for use for the dashboard
11
Dashboard
About
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://ppri.goeg.at/system/files/inline-files/Instructions_for_Use_HaDEA-2021-P3-03_17.11.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/Instructions_for_Use_HaDEA-2021-P3-03_17.11.2023_final.pdf
12
2 March 2026
survey sent
16 March
2026
1st friendly
reminder
18 March
2026
initial deadline
19 March
2026
2nd friendly
reminder
23 March
2026
extended
deadline
from 24 March
2026
individual
phone calls
and emails
31 March 2026
survey closed
April/May
2026
data validation
53 notified bodies
designated under MDR
and/or IVDR
(data status: 2 March 2026)
Final result
53 responses
(100% response rate)
About
Note: Out of 53 notified bodies, 34 NBs are designated under the MDR only, 18 NBs are
designated under both the MDR and IVDR, and 1 NB is designated under the IVDR only.
Timeline for the 20th NB survey
(conducted in March 2026 with requested data from designation up to 28/02/2026)
Response rate for the 20th NB survey
(conducted in March 2026 with requested data from designation up to 28/02/2026)
53 out of 53 notified bodies replies received (100% response rate)
13
MD
Note: Out of 53 notified bodies, 34 NBs are designated under the MDR only, 18 NBs are designated under both the MDR and IVDR, and 1 NB is
designated under the IVDR only.
100% response rate
IVD
100% response rate
About
19 19
0
2
4
6
8
10
12
14
16
18
20
Designated NBs under IVDR Replies received
IVDR designated
52 52
0
10
20
30
40
50
60
Designated NBs under MDR Replies received
MDR designated
14
2. Survey results for medical devices
Note:
• Thousands separators are represented as dots or blank space (not comma) in the graphs.
• Datasets:
The small dataset is a small set of questions asked to notified bodies every two months.
Note: From April to July 2023, it was asked monthly.
The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have
been performing since their designation.
The large dataset contains additional data asked to notified bodies once or twice a year.
MD
Ⓢ
Ⓛ
15
Small dataset
The small dataset is a small set of questions asked to notified bodies every two months.
From April to July 2023, it was asked monthly.
Ⓢ
MD
989
20.698
31.902
0 5.000 10.000 15.000 20.000 25.000 30.000 35.000
Number of applications refused for MDR (from designation up to 28/02/2026)
Number of written agreements signed (from designation up to 28/02/2026)
Number of total certification applications lodged so far (from designation up to
28/02/2026)
16
MDR applications filed and refused, written
agreements signed
Notes:
• Designated NBs for MD: 52
• Applications lodged: This number includes all applications lodged (syn. filed) so far according to MDR Annex VII section 4.3 (from the day when the
designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.:
applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were
eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates.
Pre-application activities are not included.
• Written agreements signed: This refers to the number of written agreements (contracts) between a NB and a manufacturer signed by both parties.
MD
Ⓢ
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
17
MDR number of QMS / product certificates
issued
Note QMS Certificates: This relates to Annex IX Chapter I or Annex XI Part A
according to MDR.
Note PRODUCT Certificates: This relates to Annex IX Chapter II, Annex X or
Annex XI Part B according to MDR.
MD
Ⓢ
12.036
6.373
0
2.000
4.000
6.000
8.000
10.000
12.000
14.000
Total number of QMS certificates issued
for MDR (from designation up to
28/02/2026)
Total number of QMS certificates issued
for MDR (from designation up to
28/02/2026) - thereof first time only
Number of QMS certificates issued
(total and first time only)
6.203
3.291
0
1.000
2.000
3.000
4.000
5.000
6.000
7.000
Total number of product certificates issued
for MDR (from designation up to
28/02/2026)
Total number of product certificates issued
for MDR (from designation up to
28/02/2026) - thereof first time only
Number of product certificates issued
(total and first time only)
7.970
12.125
8.343
13.883
8.564
14.275
9.422
15.530
10.132
16.664
11.053
17.941
11.708
19.368
12.324
20.704
13.646
23.553
15.363
26.497
16.395
27.315
17.729
28.512
18.173
27.830
18.476
28.594
19.050
29.410
19.455
29.439
21.003
30.871
21.426
31.864
21.791
31.101
20.698
31.902
0 5.000 10.000 15.000 20.000 25.000 30.000 35.000
Number of written agreements signed
Number of total certification applications lodged incl. no. of
applications with issued certificates
S#20: from designation up to 28/02/2026
S#19: from designation up to 31/12/2025
S#18: from designation up to 31/10/2025
S#17: from designation up to 30/08/2025
S#16: from designation up to 30/06/2025
S#15: from designation up to 30/04/2025
S#14: from designation up to 28/02/2025
S#13: from designation up to 31/12/2024
S#12: from designation up to 31/10/2024
S#11: from designation up to 31/08/2024
S#10: from designation up to 30/06/2024
S#9: from designation up to 30/04/2024
S#8: from designation up to 29/02/2024
S#7: from designation up to 31/12/2023
S#6: from designation up to 31/10/2023
S#5: from designation up to 30/08/2023
S#4: from designation up to 30/06/2023
S#3: from designation up to 31/05/2023
S#2: from designation up to 30/04/2023
18
MD
Survey comparison – March 2023 to February 2026 Ⓢ
Notes:
• S = Survey; # = number
• Survey #20: 52 designated NBs for MD
• Surveys #2 and #3 did not reach 100% response rate (#2: ~70%; #3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each
indicator.
• * Change in methodology of counting applications and written agreements by one NB in survey #13, #19 and #20, resulting in a decrease of total numbers.
*
*
*
19
MD
Survey comparison – March 2023 to February 2026 Ⓢ
Notes:
• S = Survey; # = number
• Survey #20: 52 designated NBs for MD
• Surveys #2 and #3 did not reach 100% response rate (#2: ~70%; #3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each
indicator.
* Change in methodology of counting refused applications compared to previous surveys by NBs in surveys #13 and #18.
354
409
428
435
486
510
581
638
746
834
842
853
743
995
1.058
1.115
1.157
918
944
989
0 200 400 600 800 1.000 1.200 1.400
Number of applications refused for MDR
S#20: from designation up to 28/02/2026
S#19: from designation up to 31/12/2025
S#18: from designation up to 31/10/2025
S#17: from designation up to 30/08/2025
S#16: from designation up to 30/06/2025
S#15: from designation up to 30/04/2025
S#14: from designation up to 28/02/2025
S#13: from designation up to 31/12/2024
S#12: from designation up to 31/10/2024
S#11: from designation up to 31/08/2024
S#10: from designation up to 30/06/2024
S#9: from designation up to 30/04/2024
S#8: from designation up to 29/02/2024
S#7: from designation up to 31/12/2023
S#6: from designation up to 31/10/2023
S#5: from designation up to 30/08/2023
S#4: from designation up to 30/06/2023
S#3: from designation up to 31/05/2023
S#2: from designation up to 30/04/2023
S#1: from designation up to 31/03/2023
*
*
20
MD
Survey comparison – March 2023 to February 2026 Ⓢ
S = Survey; # = number
Notes:
• Survey #20: 52 designated NBs for MD;
• Surveys #2 and #3 did not reach 100% response rate (#2: ~70%; #3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each
indicator.
• Increase from survey #1 to #3; in survey #4, the questionnaire was redesigned, and the question on “total number of certificates issued” (in addition to “first time only”) was included in
the small dataset. The redesign of the questionnaire helped the NBs to better assess the number of first-time only certificates. Therefore, the numbers of the previous surveys might be
an overestimation.
• * Change in methodology of counting by a few NBs compared to previous surveys in survey #4, #6 and #19, resulting in a decrease of total numbers.
967
1.943
1.056
2.096
1.123
2.201
1.207
1.930
1.829
2.210
1.331
2.433
1.487
2.690
1.632
2.910
1.785
3.157
2.074
3.537
2.177
3.766
2.317
4.015
2.494
4.301
2.812
4.500
2.890
4.900
3.243
5.117
3.392
6.262
3.493
7.069
3.199
6.060
3.291
6.373
0 1.000 2.000 3.000 4.000 5.000 6.000 7.000 8.000
Number of product certificates (first time only)
Number of QMS certificates (first time only)
S#20: from designation up to 28/02/2026
S#19: from designation up to 31/12/2025
S#18: from designation up to 31/10/2025
S#17: from designation up to 30/08/2025
S#16: from designation up to 30/06/2025
S#15: from designation up to 30/04/2025
S#14: from designation up to 28/02/2025
S#13: from designation up to 31/12/2024
S#12: from designation up to 31/10/2024
S#11: from designation up to 31/08/2024
S#10: from designation up to 30/06/2024
S#9: from designation up to 30/04/2024
S#8: from designation up to 29/02/2024
S#7: from designation up to 31/12/2023
S#6: from designation up to 31/10/2023
S#5: from designation up to 30/08/2023
S#4: from designation up to 30/06/2023
S#3: from designation up to 31/05/2023
S#2: from designation up to 30/04/2023
*
*
*
*
21
Medium dataset
The medium dataset is a set of questions asked to notified bodies every four months concerning the
activities they have been performing since their designation.
MD
1.840 2.721
3.920
6.188
8.120
10.818
13.177
17.846
20.424
25.987
28.037 28.489
32.920 33.107 32.898
224 340 502 1.069 1.990 2.951 3.899
5.599
6.978
8.900
10.497
12.177
14.831
17.507
18010
0
5.000
10.000
15.000
20.000
25.000
30.000
35.000
40.000
02
/2
02
1
03
/2
02
1
04
/2
02
1
05
/2
02
1
06
/2
02
1
07
/2
02
1
08
/2
02
1
09
/2
02
1
10
/2
02
1
11
/2
02
1
12
/2
02
1
01
/2
02
2
02
/2
02
2
03
/2
02
2
04
/2
02
2
05
/2
02
2
06
/2
02
2
07
/2
02
2
08
/2
02
2
09
/2
02
2
10
/2
02
2
11
/2
02
2
12
/2
02
2
01
/2
02
3
02
/2
02
3
03
/2
02
3
04
/2
02
3
05
/2
02
3
06
/2
02
3
07
/2
02
3
08
/2
02
3
09
/2
02
3
10
/2
02
3
11
/2
02
3
12
/2
02
3
01
/2
02
4
02
/2
02
4
03
/2
02
4
04
/2
02
4
05
/2
02
4
06
/2
02
4
07
/2
02
4
08
/2
02
4
09
/2
02
4
10
/2
02
4
11
/2
02
4
12
/2
02
4
01
/2
02
5
02
/2
02
5
03
/2
02
5
04
/2
02
5
05
/2
02
5
06
/2
02
5
07
/2
02
5
08
/2
02
5
09
/2
02
5
10
/2
02
5
11
/2
02
5
12
/2
02
5
01
/2
02
6
02
/2
02
6
Applications Certificates Poly. (Applications) Poly. (Certificates)
MDR applications filed and
certificates issued (sum of Annexes)
MD
22
February 2026
MDR Applications:
Total number of applications filed by Annex : 32.898*
MDR Certificates:
Total number of certificates by Annex : 18.010
∆ 2.359
∆ 948
∆ 2.698
∆ 1.932
∆ 2.268∆ 1.199
∆ 881
∆ 116
∆ 162
∆ 567
∆ 921
∆ 961
∆ 4.669
∆ 1.700
∆ 2.578
∆ 1.379
∆ 5.563
∆ 1.922
∆ 503
+2,9%
∆ -209**
-0,6%**
∆ 2.050
∆ 1.597
∆ 4.431
∆ 2.654
∆ 452
∆ 1.680
∆ 187
∆ 2.676
Notes: Designated NBs for MDR: 52
* The data shown comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set Ⓢ, as they are not able to provide complete data per Annex.
• ∆ (Delta) = Difference in MDR Applications / MDR Certificates from one survey to the next one
• Applications filed: This number includes all applications filed (syn. lodged) so far according to MDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the
Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities,
applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not
included. One application can correspond to more than one certificate.
• Certificates issued: This number includes certificates issued so far (from designation up 28/02/2026) under the MDR.
• The dotted line shows the polynomial trend line (grade 2).
• ** Change in methodology of counting by a few NBs, resulting in a decrease of total number.
**
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
1.096 677
0 67 0
1.659
947
1 114 0
2.292
1.485
0
143
0
3.635
2.240
6 305 2
4.687
2.927
3
500
3
6.212
3.859
5
739
3
8.045
4.094
5
1.026
7
9.429
4.578
12
725
24
10991
5106
13
898
14
14463
6187
21
1502
25
15594
7025
18
1676
14
16782
7463
18
1826
10
17502
8258
27
2105
12
18734
9485
27
2238
12
19117
8860
5
2302
3
0
5.000
10.000
15.000
20.000
25.000
Annex IX(I&III) Annex IX(II) Annex X Annex XI(A) Annex XI(B)
Applications survey comparison
Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 October 2023 February 2024 June 2024 October 2024 February 2025 June 2025 October 2025 February 2026
MDR applications by annex –
survey comparison
MD
23
Notes:
• Designated NBs for MDR: 52; NBs that included Annex XVI products in the numbers provided: 31
• * The data shown comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set Ⓢ, as they are not able to provide complete data per Annex.
• ** Change in methodology of counting by a few NBs, leading to decreases.
• Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to MDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication
in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities,
applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not included. One
application can correspond to more than one certificate.
February 2026 MDR Applications: 32.898*
**
** **
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
163 19 0 42 0
263
28 0 49 0
379
59 0 64 0
724
253
0 92 0
1.295
555
1 134 5
1.773
990
2
181
5
2.409
1.208
2
273
7
3.463
1.819
3
301
13
4257
2314
3
390
14
5434
2959
6
491
10
6404
3490
7
586
10
7314
4128
6
707
10
8669
5184
6
949
23
10083
6299
6
1096
23
10565
6298
4
1129
14
0
2.000
4.000
6.000
8.000
10.000
12.000
Annex IX(I&III) Annex IX(II) Annex X Annex XI(A) Annex XI(B)
Certificates survey comparison
Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 October 2023 February 2024 June 2024 October 2024 February 2025 June 2025 October 2025 February 2026
MDR certificates by annex -
survey comparison
MD
24
Notes:
• Designated NBs for MDR: 52; NBs that included Annex XVI products in the numbers provided: 31
• * The data shown comes from the medium data set
• ** Change in methodology of counting by one NB leading to a decrease
• Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the MDR by annex.
February 2026 MDR Certificates: 18.010
**
** **
677 948 1.485
2.248 2.933
3.867 4.106 4.614 5.133
6.233
7057 7491
8297
9524 8868
19 28 59 253 561 997 1.217 1.835 2.331 2.975 3507 4144
5213
6328 6316
0
2.000
4.000
6.000
8.000
10.000
12.000
Feb
2021
May
2021
Sept
2021
Apr
2022
Oct
2022
Mar
2023
Jun
2023
Oct
2023
Feb
2024
Jun
2024
Oct
2024
Feb
2025
Jun
2025
Oct
2025
Feb
2026
Product Applications and Certificates
PRODUCT Applications PRODUCT Certificates
MDR applications and certificates by type
(QMS vs Product) – survey comparison
MD
25
Note QMS Applications and Certificates: This relates to Annex IX Chapter I
or Annex XI Part A according to MDR.
Note PRODUCT Applications and Certificates: This relates to Annex IX
Chapter II, Annex X or Annex XI Part B according to MDR.
* The data shown comes from the medium data set (applications
and certificates by Annex: 3 NBs could not provide the complete
application information by Annex; hence the total number of
applications is higher - see number in the small data set).
Total number of applications lodged for changes received for already MDR issued certificates: 9.724
Note: This number is included in the total number of applications.
February 2026
MDR Applications:
Total number of applications filed by Annex : 32.898*
MDR Certificates:
Total number of certificates by Annex : 18.010
**
**
** Change in methodology of counting by one NB leading to a decrease.
1.163 1.773 2.435
3.940
5.187
6.951
9.071
10.154
11.889
15.965
17270
18608
19607
2097221419
205 312 443 816 1.429 1.954 2.682
3.764
4.647
5.925
6990
8021
9618
1117911694
0
5.000
10.000
15.000
20.000
25.000
Feb
2021
May
2021
Sept
2021
Apr
2022
Oct
2022
Mar
2023
Jun
2023
Oct
2023
Feb
2024
Jun
2024
Oct
2024
Feb
2025
Jun
2025
Oct
2025
Feb
2026
QMS Applications and Certificates
QMS Applications QMS Certificates
Specific additional procedures
according to Annex IX (II)
26
MD
Notes:
* The data shown comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set Ⓢ since they could
not provide the data per Annex.
February 2026
MDR Applications:
Total number of applications filed by Annex : 32.898*
MDR Certificates:
Total number of certificates by Annex : 18.010
1175
12
162
387
8 0
0
200
400
600
800
1000
1200
1400
Devices incorporating a medicinal substance Devices manufactured utilising, or incorporating, tissues or
cells of human or animal origin, or their derivatives, that
are non-viable or rendered non-viable
Devices that are composed of substances or of
combinations of substances that are absorbed by or locally
dispersed in the human body
Specific additional procedures according to Annex IX (II)
Applications filed requiring consultation procedure Thereof certificates issued
3.980
4.713
6.893
4.112
3.035
1.325
0
1.000
2.000
3.000
4.000
5.000
6.000
7.000
8.000
1-2 weeks 3-4 weeks 1 to 2 months 2 to 3 months 3 to 6 months >6 months
Number of files
Average timeframe between application
lodged and written agreement signed:
27
Average timeframe to written agreement signed
Note: Data of 52 notified bodies designated under MDR
MD
In the majority of the cases (65%), it takes
less than 2 months from an application
lodged to a written agreement signed.
156
131
109
85
30
13
0
20
40
60
80
100
120
140
160
180
Outside the scope of
notified body's
designation
Application not
complete
Other Wrong qualification of
product/classification of
device
Insufficient notified
body resources
Wrong conformity
assessment procedure
MDR applications - reasons for refusal
28
Notes:
• ** Applications can have multiple reasons for refusal; the total number shown is derived from the small data set and differ from the figures in the medium data
set indicated on the graph on this slide.
• February 2026: some stated “other” reasons: “cancellation/withdrawal by the customer”, “requirements not met”; “client stopped communication”, “unresolved
non-conformities, “outside the scope of insurance”, “language difference”, “voluntary renounce”.
Total number of MDR
applications:
October 2022: 8120
March 2023: 11.418
June 2023: 13.177
October 2023: 17.846*
February 2024: 20.424*
June 2024: 26.185*
October 2024: 28.069*
February 2025: 28.489*
June 2025: 32.974*
October 2025: 33.292*
February 2026: 32.898*
February 2026
Main reasons
- “Outside the scope of NB
designation” (30%)
- “Applications not complete” (25%)
Number of application
refusals**:
October 2022: 232
March 2023: 269
June 2023: 328
October 2023: 367
February 2024: 454
June 2024: 576
October 2024: 562
February 2025: 650
June 2025: 727
October 2025: 918
February 2026: 989
MD
* The total number comes from the medium data set
– except for a few NBs where the total number of
applications filed was derived from the small data set
Ⓢ since they could not provide complete data per
Annex.
Completeness of submissions
*Estimated percentage of submissions which were deemed satisfactory in terms of documentation provided (before undertaking the
review of its content) without requesting for any additional information
29
N
um
be
r o
f n
ot
ifi
ed
b
od
ie
s
MD
Number of notified bodies which
report that > 50% of submissions
are considered complete:
14 out of 52 NBs designated
under MDR in February 2026
Incomplete submissions
remain high*
15
21 18
13
17
23 22 22
14 15 15
7
12
12
16
16
15 15 13
17
22 23
5
2
4 5
7
9 9 13 18
12 12
5
3 4 5
3
2 4 2 1 2 2
0
10
20
30
40
50
60
Oct 22 Mar 23 June 23 Oct 23 Feb 24 June 24 Oct 24 Feb 25 June 25 Oct 25 Feb 26
Completeness of submissions expressed by notified bodies* (in number of NBs)
(Annex VII, Section 4.3) – survey comparison
Less than 25 % 25-50 % 51-75 % More than 75 %
Time to reach a new certificate
(QMS vs QMS+PRODUCT)
30
Notes:
• This indicator shows the time to reach issuance of a new EC certificate (from written agreement signed to issuance) under MDR
• QMS+PRODUCT: Data of 39 NBs designated under MDR; 13 NBs indicated that no QMS+PRODUCT certificate was issued yet
• QMS: Data of 47 NBs designated under MDR; 5 NBs indicated that no QMS certificate was issued yet
Pe
rc
en
ta
ge
(%
) o
f t
ot
al
n
um
be
r o
f N
B
th
at
h
av
e
is
su
ed
c
er
tif
ic
at
es
MD
February 2026
MDR Applications: 32.898*
MDR Certificates: 18.010
* The total number comes from the medium data set
– except for 3 NBs where the total number of
applications filed was derived from the small data set
Ⓢ, as they are not able to provide complete data per
Annex
MDR QMS certificates
- 62% of NBs: 13-18 months to issue a new QMS
certificate
- 30% of NBs: 6-12 months
MDR QMS+PRODUCT certificates: longer time
- 51% of NBs: 13-18 months
- 31% of NBs: 19-24 months
0%
8%
51%
31%
10%
2%
30%
62%
2%
4%
0% 10% 20% 30% 40% 50% 60% 70%
<6 months
6-12 months
13-18 months
19-24 months
>24 months
Time to reach a new certificate
(QMS vs QMS+PRODUCT)
MDR_QMS MDR_QMS+PRODUCT
Questions on Annex XVI products
(products with no intended medical purpose that fall under the scope of the MDR)
31
Notes:
16th NB survey: 22 out of 50 NBs entered "0" for all questions relating to Annex XVI products
18th NB survey: 23 out of 50 NBs entered "0" for all questions relating to Annex XVI products.
20th NB survey: 23 out of 52 NBs entered "0" for all questions relating to Annex XVI products.
MD
126
297
70
124
290
65
132
290
65
0 50 100 150 200 250 300 350
Estimation of transit of MDD certificates for Annex XVI products to the MDR without
maintaining the medical purpose for the covered devices
Received requests to sign a written agreement for a conformity assessment procedure
of an Annex XVI product, in accordance with the condition established in Article 2(2) of
Regulation (EU) 2022/2346, from 01/01/2023
Received requests to sign a written agreement for a conformity assessment procedure
of an Annex XVI product, in accordance with the condition established in Article 2(1) of
Regulation (EU) 2022/2346, from 01/01/2023
16th NB Survey (data from designation up to 30/06/2025) 18th NB Survey (data from designation up to 31/10/2025) 20th NB Survey (data from designation up to 28/02/2026)
32
Certificates issued for products without an intended
medical purpose* and for dual purpose devices**
LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED
MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) MDR
1. Contact lenses or other items intended to be introduced into or
onto the eye.
2. Products intended to be totally or partially introduced into the
human body through surgically invasive means for the purpose of
modifying the anatomy or fixation of body parts with the
exception of tattooing products and piercings.
3. Substances, combinations of substances, or items intended to be
used for facial or other dermal or mucous membrane filling by
subcutaneous, submucous or intradermal injection or other
introduction, excluding those for tattooing.
4. Equipment intended to be used to reduce, remove or destroy
adipose tissue, such as equipment for liposuction, lipolysis or
lipoplasty.
5. High intensity electromagnetic radiation (e.g. infra-red, visible
light and ultra-violet) emitting equipment intended for use on the
human body, including coherent and non-coherent sources,
monochromatic and broad spectrum, such as lasers and intense
pulsed light equipment, for skin resurfacing, tattoo or hair
removal or other skin treatment.
6. Equipment intended for brain stimulation that apply electrical
currents or magnetic or electromagnetic fields that penetrate the
cranium to modify neuronal activity in the brain.
Notes: Data of 13 NBs; 38 out of 51 NBs entered "0“ for all groups
MD
* Products without an intended medical purpose that are listed in Annex XVI to the MDR are covered by that Regulation from 22 June 2023, which is the date of
application of Annex XVI common specifications set out in Commission Implementing Regulation (EU) 2022/2346.
** Dual purpose devices: products having both a medical and a non-medical intended purpose
Notes: Data of 13 NBs; 39 out of 52 NBs entered "0“ for all groups
4 31
22
31
34 4
9 10
0 0
0
10
20
30
40
Total number of certificates issued so far for products
without an intended medical purpose
Total number of certificates issued for dual purpose
devices
18th NB Survey (data from designation up to 31/10/2025)
Group 1 Group 2 Group 3 Group 4 Group 5 Group 6
4 32
24
42
65 5
13
19
0 0
0
10
20
30
40
50
Total number of certificates issued so far for products
without an intended medical purpose
Total number of certificates issued for dual purpose
devices
20th NB Survey (data from designation up to 28/02/2026)
Group 1 Group 2 Group 3 Group 4 Group 5 Group 6
33
Single-use devices and their reprocessing
(Article 17 MDR)
Data of 52 NBs designated under MDR
One NB indicated issuance of
certificates:
• 8 certificates issued in
accordance with Art. 17(2)
• No certificates issued in
accordance with Art. 17(5)
MD
1
31
20
Yes, certificate issued
Not applicable (not in the
designation scope of the
NB)
No certificates issued yet
(although in the designation
scope of the NB)
34
Article 117 MDR opinions* - requests
received and opinions issued
* Article 117 MDR: Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and
of the Council, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with
the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by
a notified body allowing the manufacturer to affix a CE marking to the medical device.
If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used
separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of
the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that
Regulation for the type of device in question.
MD
Notes 18th NB survey:
• Total number of requests for Article 117 MDR opinions for initial market authorization submissions received: data of 25 NBs
• Total number of requests for Article 117 MDR opinions for changes received: data of 6 NBs
Notes 20th NB survey:
• Total number of requests for Article 117 MDR opinions for initial market authorization submissions received: data of 26 NBs
• Total number of requests for Article 117 MDR opinions for changes received: data of 7 NBs
474
37
367
23
0
200
400
600
Opinions for initial market authorisation submissions Opinions for changes
18th NB Survey (data from designation up to 31/10/2025)
Total number of applications for Article 117 MDR opinions received Total number of Article 117 MDR opinions issued
553
46
437
33
0
200
400
600
Opinions for initial market authorisation submissions Opinions for changes
20th NB Survey (data from designation up to 28/02/2026)
Total number of applications for Article 117 MDR opinions received Total number of Article 117 MDR opinions issued
35
3. Survey results for
in vitro diagnostic medical devices
IVD
Note:
• Thousands separators are represented as dots or blank space (not comma) in the graphs.
• Datasets:
The small dataset is a small set of questions asked to notified bodies every two months.
Note: From April to July 2023, it was asked monthly.
The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have
been performing since their designation.
The large dataset contains additional data asked to notified bodies once a year.
Ⓢ
Ⓛ
36
IVDR applications filed and refused, written
agreements signed
IVD
Notes:
• Designated NBs for IVD: 19
• Applications lodged: This number includes all applications lodged (syn. filed) so far according to IVDR Annex VII section 4.3 (from the day when the designation
became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates,
applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer
(including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not included.
• Written agreements signed: This refers to the number of written agreements (contracts) between a NB and a manufacturer signed by both parties.
Ⓢ
145
1.813
3.723
0 500 1.000 1.500 2.000 2.500 3.000 3.500 4.000
Number of applications refused for IVDR (from designation up to 28/02/2026)
Number of written agreements signed (from designation up to 28/02/2026)
Number of total certification applications lodged so far (from designation up to 28/02/2026)
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
37
IVDR Number of QMS / product certificates
issued
Note QMS Certificates: This relates to Annex IX Chapter I or Annex XI
according to IVDR.
Note PRODUCT Certificates: This relates to Annex IX Chapter II or Annex X
according to IVDR.
IVD
Ⓢ
1.302
1.007
0
200
400
600
800
1.000
1.200
1.400
Total number of product certificates issued
for IVDR (from designation up to
28/02/2026)
Total number of product certificates issued
for IVDR (from designation up to
28/02/2026) - thereof first time only
Number of product certificates issued
(total and first time only)
1.040
565
0
200
400
600
800
1.000
1.200
Total number of QMS certificates issued for
IVDR (from designation up to 28/02/2026)
Total number of QMS certificates issued for
IVDR (from designation up to 28/02/2026) -
thereof first time only
Number of QMS certificates issued
(total and first time only)
38
Survey comparison – March 2023 to February 2026
S = Survey; # = number
Notes:
• Designated NBs for IVDs: S#1 to S#5: 10; S#6 to S#11: 12; S#12 to S#13: 13; S#14: 14; S#15: 16, S#16: 17, S#17: 18, S#18-#20: 19
• Surveys #2 and #3 did not reach 100% response rate (S#2: ~70%; S#3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator.
IVD
Ⓢ
521
1.014
543
1.071
571
1.111
609
1.157
683
1.295
736
1.451
785
1.565
845
1.694
913
1.821
1.004
2.017
1.046
2.181
1.107
2.341
1.163
2.388
1.195
2.532
1.256
2.742
1.463
3.011
1.571
3.155
1.728
3.531
1.753
3.605
1.813
3.723
0 500 1.000 1.500 2.000 2.500 3.000 3.500 4.000
Number of written agreements signed
Number of total certification applications lodged incl. no. of
applications with issued certificates
S#20: from designation up to 28/02/2026
S#19: from designation up to 31/12/2025
S#18: from designation up to 31/10/2025
S#17: from designation up to 30/08/2025
S#16: from designation up to 30/06/2025
S#15: from designation up to 30/04/2025
S#14: from designation up to 28/02/2025
S#13: from designation up to 31/12/2024
S#12: from designation up to 31/10/2024
S#11: from designation up to 31/08/2024
S#10: from designation up to 30/06/2024
S#9: from designation up to 30/04/2024
S#8: from designation up to 29/02/2024
S#7: from designation up to 31/12/2023
S#6: from designation up to 31/10/2023
S#5: from designation up to 30/08/2023
S#4: from designation up to 30/06/2023
S#3: from designation up to 31/05/2023
39
Survey comparison – March 2023 to February 2026
S = Survey; # = number
Notes:
• Designated NBs for IVDs: S#1 to S#5: 10; S#6 to S#11: 12; S#12 to S#13: 13; S#14: 14; S#15: 16, S#16:16, S#17: 18, S#18-#20: 19 (1 NB reporting 127 refused applications)
• Surveys #2 and #3 did not reach 100% response rate (S#2: ~70%; S#3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator.
• * Change in methodology of counting refused applications compared to previous surveys by NBs in survey #12.
IVD
Ⓢ
30
32
35
40
41
44
45
47
55
64
75
68
72
84
97
104
106
111
113
145
0 20 40 60 80 100 120 140 160
Number of applications refused for IVDR
S#20: from designation up to 28/02/2026
S#19: from designation up to 31/12/2025
S#18: from designation up to 31/10/2025
S#17: from designation up to 30/08/2025
S#16: from designation up to 30/06/2025
S#15: from designation up to 30/04/2025
S#14: from designation up to 28/02/2025
S#13: from designation up to 31/12/2024
S#12: from designation up to 31/10/2024
S#11: from designation up to 31/08/2024
S#10: from designation up to 30/06/2024
S#9: from designation up to 30/04/2024
S#8: from designation up to 29/02/2024
S#7: from designation up to 31/12/2023
S#6: from designation up to 31/10/2023
S#5: from designation up to 30/08/2023
S#4: from designation up to 30/06/2023
S#3: from designation up to 31/05/2023
*
40
IVD
ⓈSurvey comparison – March 2023 to February 2026
S = Survey; # = number
Notes:
• Designated NBs for IVDs: S#1 to S#5: 10; S#6 to S#11: 12; S#12 to S#13: 13; S#14: 14; S#15: 16, S#16: 17, S#17: 18, S#18 & #19: 19
• Surveys #2 and #3 did not reach 100% response rate (S#2: ~70%; S#3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator.
• * One NB revised its methodology for counting QMS certificates in survey #19, resulting in a decrease of total numbers.
169
169
177
177
202
183
235
190
283
206
287
231
347
244
371
252
416
282
460
318
523
336
580
368
629
390
678
408
712
434
788
450
876
642
913
655
964
536*
1.007
565
0 200 400 600 800 1.000 1.200
Number of product certificates (first time only)
Number of QMS certificates (first time only)
S#20: from designation up to 28/02/2026
S#19: from designation up to 31/12/2025
S#18: from designation up to 31/10/2025
S#17: from designation up to 30/08/2025
S#16: from designation up to 30/06/2025
S#15: from designation up to 30/04/2025
S#14: from designation up to 28/02/2025
S#13: from designation up to 31/12/2024
S#12: from designation up to 31/10/2024
S#11: from designation up to 31/08/2024
S#10: from designation up to 30/06/2024
S#9: from designation up to 30/04/2024
S#8: from designation up to 29/02/2024
S#7: from designation up to 31/12/2023
S#6: from designation up to 31/10/2023
S#5: from designation up to 30/08/2023
S#4: from designation up to 30/06/2023
S#3: from designation up to 31/05/2023
41
Medium dataset
The medium dataset is a set of questions asked to notified bodies every four months concerning the
activities they have been performing since their designation.
IVD
249 345
512
648
822
950
1.155
1.479
1634
1747
2200
2395
3083
3304
3418
7 11 31 125
268 331
500
639
798
940
1273
1490
1779
2192
2318
0
500
1000
1500
2000
2500
3000
3500
4000
02
/2
02
1
03
/2
02
1
04
/2
02
1
05
/2
02
1
06
/2
02
1
07
/2
02
1
08
/2
02
1
09
/2
02
1
10
/2
02
1
11
/2
02
1
12
/2
02
1
01
/2
02
2
02
/2
02
2
03
/2
02
2
04
/2
02
2
05
/2
02
2
06
/2
02
2
07
/2
02
2
08
/2
02
2
09
/2
02
2
10
/2
02
2
11
/2
02
2
12
/2
02
2
01
/2
02
3
02
/2
02
3
03
/2
02
3
04
/2
02
3
05
/2
02
3
06
/2
02
3
07
/2
02
3
08
/2
02
3
09
/2
02
3
10
/2
02
3
11
/2
02
3
12
/2
02
3
01
/2
02
4
02
/2
02
4
03
/2
02
4
04
/2
02
4
05
/2
02
4
06
/2
02
4
07
/2
02
4
08
/2
02
4
09
/2
02
4
10
/2
02
4
11
/2
02
4
12
/2
02
4
01
/2
02
5
02
/2
02
5
03
/2
02
5
04
/2
02
5
05
/2
02
5
06
/2
02
5
07
/2
02
5
08
/2
02
5
09
/2
02
5
10
/2
02
5
11
/2
02
5
12
/2
02
5
01
/2
02
6
02
/2
02
6
Applications Certificates Poly. (Applications)
IVDR applications lodged and
certificates issued
42
February 2026
IVDR Applications: 3.418
IVDR Certificates: 2.318
Notes: Designated NBs for IVDR in February: 19
• ∆ (Delta) = Difference in IVDR Applications / IVDR Certificates from one survey to the next one
• Applications lodged: This number includes all applications lodged (syn. filed) so far according to IVDR Annex VII section 4.3 (from the day when the designation
became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates,
applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer
(including transferred applications), applications lodged for changes of existing IVDR certificates. Pre-application activities are not included. One application can
correspond to more than one certificate.
• Certificates issued: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR.
• The dotted line shows the polynomial trend line (grade 2).
∆ 96
∆ 4
∆ 167
∆ 20
∆ 136
∆ 94
∆ 174
∆ 143
∆ 128
∆ 63
∆ 205
∆ 169
IVD
∆ 139
∆ 324
∆ 155
∆ 159
∆ 113
∆ 333
∆ 453
∆ 142
∆ 114
+4%
∆ 126
+6%
∆ 217
∆ 195
∆ 688
∆ 289
∆ 221
∆ 413
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
IVDR applications and certificates by annex
43
Notes:
• Applications lodged by annex: This number includes all applications lodged
(syn. filed) by annex according to IVDR Annex VII section 4.3 (from the day
when the designation became valid, i.e. one day after publication in NANDO to
the date of the survey up to 28/02/2026), i.e.: applications with issued
certificates, applications without decisions on the outcome of the conformity
assessment activities, applications that were eventually refused or withdrawn by
the manufacturer (including transferred applications), applications lodged for
changes of existing MDR certificates. Pre-application activities are not included.
One application can correspond to more than one certificate.
• Certificates issued by annex: This number includes certificates issued so far
(from designation up to 28/02/2026) under the IVDR by annex.
• Class D devices are included in the total number of applications/certificates.
• * Change in methodology of counting compared to previous surveys by one NB.
February 2026
IVDR Applications: 3.418
IVDR Certificates: 2.318
IVD
1428
1976
0 14
1008
1300
0 10
0
500
1000
1500
2000
2500
Annex IX(I&III) Annex IX(II) Annex X Annex XI
Total IVDR applications/certificates
by Annex
Applications Certificates
*
*
6 1 0 09 2 0 020 11 0 059 66 0 0
154 114
0 0
159 164
0 8
255 237
0 8
321 315
0 3
384 410
0 4
489 446
0 5
594
673
0 6
692
791
0 7
848
922
0 9
1078 1105
0 9
1008
1300
0 10
0
200
400
600
800
1000
1200
1400
Annex IX(I&III) Annex IX(II) Annex X Annex XI
Certificates survey comparison
Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 Oct 2023 Feb 2024 June 2024 Oct 2024 Feb 2025 June 2025 Oct 2025 Feb 2026
86 163
0 0
127 216
0 2
205 307
0 0
296 352
0 0
357 465
0 0
395
534
0 21
486
646
0 23
715 759
0 5
767 860
0 7
819 921
0 7
1020
1169
0 11
1089
1295
0 11
1534 1537
0 12
1525
1765
0 14
1428
1976
0 14
0
500
1000
1500
2000
2500
Annex IX(I&III) Annex IX(II) Annex X Annex XI
Applications survey comparison
Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 Oct 2023 Feb 2024 June 2024 Oct 2024 Feb 2025 June 2025 Oct 2025 Feb 2026
IVDR applications and certificates by annex –
surveys comparison
44
February 2026 IVDR Certificates: 2.318
February 2026 IVDR Applications: 3.418
Notes:
• Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to IVDR Annex VII section 4.3 (from the day when the
designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued
certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the
manufacturer (including transferred applications), applications lodged for changes of existing IVDR certificates. Pre-application activities are not included. One application
can correspond to more than one certificate.
• Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR by annex.
• * Change in methodology of counting compared to previous surveys by one NB, resulting in a decrease of total numbers.
IVD
*
*
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
Class D devices
applications and certificates
45
Notes:
• Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to IVDR Annex VII
section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to
the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the
conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred
applications), applications lodged for changes of existing IVDR certificates. Pre-application activities are not included. One application
can correspond to more than one certificate.
• Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR by
annex.
February 2026:
Total number of Class D devices Applications: 1.191
Total number of Class D devices Certificates: 722
IVD
February 2026
IVDR Applications: 3.418
IVDR Certificates: 2.318
257
934
0 0
166
556
0 0
0
100
200
300
400
500
600
700
800
900
1000
Annex IX(I&III) Annex IX(II) Annex X Annex XI
Class D devices applications/certificates by annex
Applications Certificates
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
Class D IVDs applications
and certificates development
46
Note:
Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex
according to IVDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one
day after publication in NANDO to the date of the survey up to 28/02/2026), i.e.: applications with
issued certificates, applications without decisions on the outcome of the conformity assessment
activities, applications that were eventually refused or withdrawn by the manufacturer (including
transferred applications), applications lodged for changes of existing MDR certificates. Pre-
application activities are not included. One application can correspond to more than one certificate.
IVD
Note:
Certificates issued by annex: This number includes certificates issued so far (from designation up
to 28/02/2026) under the IVDR by annex.
February 2026:
Total number of Class D devices applications: 1.191
Total number of Class D devices certificates: 722
33
149
0 0
48
179
0 0
68
268
0 0
71
299
0 0
124
392
0 0
157
501
0 0
167
598
0 0
204
747
0 0
249
848
0 0
257
934
0 0
0
100
200
300
400
500
600
700
800
900
1000
Annex IX(I&III) Annex IX(II) Annex X Annex XI
Class D devices applications by annex
Class D devices applications by annex March 2023
Class D devices applications by annex June 2023
Class D devices applications by annex October 2023
Class D devices applications by annex February 2024
Class D devices applications by annex June 2024
Class D devices applications by annex October 2024
Class D devices applications by annex February 2025
Class D devices applications by annex June 2025
Class D devices applications by annex October 2025
Class D devices applications by annex February 2026
2
25
0 07
55
0 020
99
0 0
26
147
0 0
57
213
0 0
95
282
0 0
128
338
0 0
139
412
0 0
161
469
0 0
166
556
0 0
0
100
200
300
400
500
600
Annex IX(I&III) Annex IX(II) Annex X Annex XI
Class D devices certificates by annex
Class D devices certificates by annex March 2023
Class D devices certificates by annex June 2023
Class D devices certificates by annex October 2023
Class D devices certificates by annex February 2024
Class D devices certificates by annex June 2024
Class D devices certificates by annex October 2024
Class D devices certificates by annex February 2025
Class D devices certificates by annex June 2025
Class D devices certificates by annex October 2025
Class D devices certificates by annex February 2026
16
0 1 0
24
0 2 0
26
0
6
0
27
0
6
0
33
0
11
0
39
0
17
0
42
0
20
0
51
0
21
0
63
0
22
0
80
0
30
0
0
10
20
30
40
50
60
70
80
90
Applications lodged requiring consultation for
CDx
of which applications for Class D devices Certificates issued requiring consultation for
CDx
of which certificates for Class D devices
Applications lodged and certificates issued requiring consultation for companion diagnostics
S#1: from designation up to 31/03/2023 S#4: from designation up to 30/06/2023 S#6: from designation up to 31/10/2023 S#8: from designation up to 29/02/2024
S#10: from designation up to 30/06/2024 S#12: from designation up to 31/10/2024 S#14: from designation up to 28/02/2025 S#16: from designation up to 30/06/2025
S#18: from designation up to 31/10/2025 S#20: from designation up to 28/02/2026
47
Applications and certificates requiring
consultation for companion diagnostics (CDx)*
February 2026
Class D devices applications: 1.191
Class D devices certificates: 722
IVD
* According to Article 2 (7) IVDR, a companion diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:
(a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
(b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.
20th NB survey: data of 3 NBs
Applications Certificates
February 2026
IVDR Applications: 3.418
IVDR Certificates: 2.318
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746
Has a Class D application been lodged
from 1 October 2024 in any of the following
four categories of currently designated
EURLs?
48
Collaboration with EU reference laboratories
(EURLs) on Class D devices (1)
Data of 19 NBs designated under IVDR
Has a Class D certificate been issued in
any of the following six categories of
currently designated EURLs?
IVD
9
3
5
2
10
16
14
17
0 5 10 15 20
Hepatitis and retroviruses
Respiratory viruses
Bacterial pathogens (syphilis)
Herpes viruses
Yes No Number of NBs
5
2
3
3
3
5
14
17
16
16
16
14
0 5 10 15 20
Hepatitis and retroviruses
Respiratory viruses
Bacterial pathogens (syphilis)
Herpes viruses
Parasites
Blood grouping
Yes No Number of NBs
Hepatitis
and
retroviruses
Respiratory
viruses
Bacterial
pathogens
Herpes
virus
TOTAL
Total number of class D devices (covered by an
application lodged [from 01/10/2024 up to 28/02/2026])
that fall in the categories of currently designated EURLs
270 37 41 9 357
Number of devices covered by a signed master services
agreement with an EURL for performance verification
(EURL task in IVDR Article 100(2)(a) [as of 28/02/2026]
438 9 30 27 504
Number of devices that is or was covered by a signed
statement of work with an EURL for performance
verification (EURL task in IVDR Article 100(2)(a)) [as of
28/02/2026]
25 0 0 0 25
Number of devices for which performance verification by
EURLs has been scheduled or completed [as of
28/02/2026]
81 0 0 0 81
49
Collaboration with EU reference laboratories
(EURLs) on Class D devices (2)
Class D applications
IVD
Data of 9 NBs designated under IVDR
Hepatitis
and
retrovirus
Respiratory
viruses
Bacterial
pathogens
Herpes
virus
Parasites Blood
grouping
TOTAL
Total number of class D devices (covered by issued certificates [as of
28/02/2026]) that fall in the categories of currently designated EURLs* 477 19 37 45 8 181 767
Number of devices covered by a signed master services agreement
with an EURL for batch testing (EURL task in IVDR Article 100(2)(b)) [as
of 28/02/2026]*
468 8 33 29 3 73 614
Number of devices covered by a signed statement of work with an
EURL for patch testing (EURL task in IVDR Article 100(2)(a)) [as of
28/02/2026]
412 8 29 27 n. a. n. a. 476
Number of devices for which batch testing by EURLs is in practical
operation [as of 28/02/2026]** 190 3 0 0 n. a. n. a. 193
Number of batches tested by an EURL from the date on which the
corresponding EURLs became available for tasks in conformity
assessment (1 October 2024) [as of 28/02/2026]* Note: cumulative sum
across devices in category
813 28 0 0 n. a. n. a. 841
Number of batches tested by alternative means (e.g. by an independent
testing laboratory) from the date on which the corresponding EURLs
became available for tasks in conformity assessment (1 October 2024) [as
of 28/02/2026]***
373 0 13 5 n. a. n. a. 391
50
Collaboration with EU reference laboratories
(EURLs) on Class D devices (3)
Class D certificates
IVD
Data of 5 NBs designated under IVDR
n.a. = data not available (question was not asked in the survey)
* This question was asked in the 20th NB survey for the first time for the following two categories: Parasites, Blood grouping.
** Note: this refers to the overall process being in place in practice, and not whether a batch is being tested at the time of reporting.
*** This question was asked in the 18th NB survey for the first time.
51
Comparison of EURLs results
• 14th NB survey: data of 4 NBs designated under IVDR
• 16th NB survey: data of 8 NBs designated under IVDR
• 18th NB survey: data of 9 NBs designated under IVDR
• 20th NB survey: data of 9 NBs designated under IVDR
• 14th NB survey: data of 3 NBs designated under IVDR
• 16th NB survey: data of 3 NBs designated under IVDR
• 18th NB survey: data of 4 NBs designated under IVDR
• 20th NB survey: data of 5 NBs designated under IVDR
* This question was not asked in this survey round. n.a. = not available;
** Differing questions in the 16th and 18th NB surveys:
• 16th NB survey: Number of batches tested [as of 30/06/2025]
• 18th NB survey: Number of batches tested by an EURL from the date on which the
corresponding EURLs became available for tasks in conformity assessment (1 October 2024) [as of 31/10/2025]
24
23
0
4
124
397
14
14
168
496
22
50
357
504
25
81
0 100 200 300 400 500 600
Total number of class D devices (covered by an
application lodged) that fall in the categories of
currently designated EURLs
Number of devices covered by a signed master
services agreement with an EURL for performance
verification (EURL task in IVDR Article 100(2)(a)
Number of devices that is or was covered by a
signed statement of work with an EURL for
performance verification (EURL task in IVDR
Article 100(2)(a))
Number of devices for which performance
verification by EURLs has been scheduled or
completed
Class D applications
14th NB survey [as of 28/02/2025] 16th NB survey [as of 30/06/2025]
18th NB survey [as of 31/10/2025] 20th NB survey [as of 28/02/2026]
222
139
91
41
n.a.*
n.a.*
564
388
340
78
221**
n.a.*
619
589
476
165
504**
294
767
614
476
193
841
391
0 100 200 300 400 500 600 700 800 900
Total number of class D devices (covered by issued
certificates) that fall in the categories of currently
designated EURLs
Number of devices covered by a signed master services
agreement with an EURL for batch testing (EURL task
in IVDR Article 100(2)(b)
Number of devices covered by a signed statement of
work with an EURL for batch testing (EURL task in
IVDR Article 100(2)(b))
Number of devices for which batch testing by EURLs is
in practical operation
Number of batches tested by an EURL from the date on
which the corresponding EURLs became available for
tasks in conformity assessment (1 October 2024)
Number of batches tested by alternative means from
the date on which the corresponding EURLs became
available for tasks in conformity assessment
Class D certificates
14th NB survey [as of 28/02/2025] 16th NB survey [as of 30/06/2025]
18th NB survey [as of 31/10/2025] 20th NB survey [as of 28/02/2026]
12
4
3
1
0 0
0
2
4
6
8
10
12
14
Other Wrong qualification of
product/classification
of device
Application not
complete
Insufficient notified
body resources
Wrong conformity
assessment
procedure
Outside the scope of
notified body's
designation
Reasons for refusal
52
IVDR applications - reason for refusal
Total number of IVDR
application refusals*:
October 2022: 2
March 2023: 49
June 2023: 16
October 2023: 6
February 2024: 7
June 2024: 7
October 2024: 7
February 2025: 12
June 2025: 14
October 2025: 111
February 2026: 145
February 2026
Main reasons for refusals:
“Other” (60%)
IVD
Notes:
• * Applications can have multiple reasons for refusal; the total number shown is derived from the small data set and differ from the figures in the medium data set indicated
on the graph on this slide."
• February 2026: ”Other” reasons: “not able to complete conformity assessment process”, “client stopped communication”, “cancelled by the manufacturer”.
February 2026
IVDR Applications: 3.418
IVDR Certificates: 2.318
Completeness of submissions
* Estimated percentage of submissions which were deemed satisfactory in terms of documentation provided (before
undertaking the review of its content) without requesting for any additional information
53
N
um
be
r o
f n
ot
ifi
ed
b
od
ie
s
IVD
Number of notified bodies which
report that > 50% of submissions
are considered complete:
5 out of 19 NBs in February 2026
2
4
2 2 2 2 2 3
5 4
6
83
3 6 5
7 7 7
8
6 7
6
6
1
0
1 2
1 1 2
2 3
5
6
4
0
0
1 1
2 2 1
0
0
1
1 1
0
2
4
6
8
10
12
14
16
18
20
April 2022 October
2022
March
2023
June 2023 October
2023
February
2024
June 2024 October
2024
February
2025
June 2025 October
2025
February
2026
Completeness of submissions expressed by notified bodies (in percent
of notified bodies) (Annex VII, Section 4.3) – survey comparison
Less than 25 % 25-50 % 51-75 % More than 75 %
Submissions remain incomplete*
229
1.026
876
540
323
134
0
200
400
600
800
1.000
1.200
1-2 weeks 3-4 weeks 1 to 2 months 2 to 3 months 3 to 6 months >6 months
Number of files
Average timeframe between application
lodged and written agreement signed
54
Average timeframe to written agreement signed
Note: Data of 19 NBs designated under IVDR
In the majority of the cases (68%), it takes
less than 2 months from an application
lodged to a written agreement signed.
IVD
Time to reach a new certificate
(QMS vs QMS+PRODUCT)
55
Notes:
• This indicator shows the time to reach issuance of a new EC certificate (from written agreement signed to issuance) under IVDR.
• QMS+PRODUCT: Data of 12 NBs designated under IVDR
• QMS: Data of 12 NBs designated under IVDR
IVDR QMS certificates
- 42% of NBs: 6-12 months to issue a new QMS
certificate
- 50% of NBs: 13-18 months
IVDR QMS+PRODUCT certificates: longer time
- 67% of NBs: 13-18 months
- 8% of NBs: 19-24 months
IVD
Pe
rc
en
ta
ge
(%
) o
f t
ot
al
n
um
be
r o
f N
B
th
at
h
av
e
is
su
ed
c
er
tif
ic
at
es February 2026
IVDR Applications: 3.418
IVDR Certificates: 2.318
0%
25%
67%
8%
0%
0%
42%
50%
8%
0%
0% 10% 20% 30% 40% 50% 60% 70%
<6 months
6-12 months
13-18 months
19-24 months
>24 months
Time to reach IVDR certificate
(QMS vs QMS+PRODUCT)
IVDR_QMS IVDR_QMS+PRODUCT
Thank you
Contact for questions: medical.devices@goeg.at
Austrian National Public Health Institute/ Gesundheit Österreich (GÖG)
© European Union 2026
Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that are
not owned by the EU, permission may need to be sought directly from the respective right holders.
56
mailto:medical.devices@goeg.at
https://creativecommons.org/licenses/by/4.0/
Study supporting the �monitoring of the availability�of medical devices on the EU market
Disclaimer
Acknowledgements
Content
List of abbreviations (1)
List of abbreviations (2)
1. About the study, survey and datasets
Study supporting the monitoring of availability of medical devices on the EU market
Preliminary notes
NB survey overview
Dashboard
Foliennummer 12
Response rate for the 20th NB survey �(conducted in March 2026 with requested data from designation up to 28/02/2026)
2. Survey results for medical devices
Small dataset
MDR applications filed and refused, written agreements signed
MDR number of QMS / product certificates issued
Foliennummer 18
Foliennummer 19
Foliennummer 20
Medium dataset
MDR applications filed and �certificates issued (sum of Annexes)
MDR applications by annex – �survey comparison
MDR certificates by annex - �survey comparison
MDR applications and certificates by type �(QMS vs Product) – survey comparison
Specific additional procedures �according to Annex IX (II)
Average timeframe to written agreement signed
MDR applications - reasons for refusal
Completeness of submissions
Time to reach a new certificate�(QMS vs QMS+PRODUCT)
Questions on Annex XVI products �(products with no intended medical purpose that fall under the scope of the MDR)
Certificates issued for products without an intended �medical purpose* and for dual purpose devices**
Single-use devices and their reprocessing (Article 17 MDR)
Article 117 MDR opinions* - requests received and opinions issued
3. Survey results for �in vitro diagnostic medical devices
IVDR applications filed and refused, written agreements signed
IVDR Number of QMS / product certificates issued
Survey comparison – March 2023 to February 2026
Survey comparison – March 2023 to February 2026
Foliennummer 40
Medium dataset
IVDR applications lodged and �certificates issued
IVDR applications and certificates by annex
IVDR applications and certificates by annex – surveys comparison
Class D devices �applications and certificates
Class D IVDs applications �and certificates development
Applications and certificates requiring consultation for companion diagnostics (CDx)*
Collaboration with EU reference laboratories (EURLs) on Class D devices (1)
Collaboration with EU reference laboratories (EURLs) on Class D devices (2)�Class D applications
Collaboration with EU reference laboratories (EURLs) on Class D devices (3)�Class D certificates
Comparison of EURLs results
IVDR applications - reason for refusal
Completeness of submissions
Average timeframe to written agreement signed
Time to reach a new certificate�(QMS vs QMS+PRODUCT)
Thank you��Contact for questions: medical.devices@goeg.at ��Austrian National Public Health Institute/ Gesundheit Österreich (GÖG)
06.07.2026
Datei
PD
Seite 1/2
Gemeinsame Bekanntmachung des Paul-Ehrlich-Instituts
und des Bundesinstituts für Arzneimittel und
Medizinprodukte
Umstellung bei der Beantragung von Eingangsnummern (ENR) und EU-
Verfahrensnummern (EUV) bei nationalen und dezentralisierten
Zulassungsverfahren
Ab dem 01. September 2026 steht die PharmNet.Bund-Anwendung zur Beantragung
der Eingangsnummer (ENR) und EU-Verfahrensnummer (EUV) bei nationalen und
dezentralisierten Verfahren in Zuständigkeit des Paul-Ehrlich-Instituts (PEI),
Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, und des
Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) zur Verfügung.
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06.07.2026
Datei
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6 July 20261
EMA/PRAC/124080/2026
Pharmacovigilance Risk Assessment Committee (PRAC)
PRAC recommendations on signals
Adopted at the 8-11 June 2026 PRAC meeting
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk
Assessment Committee (PRAC) on the signals discussed during the meeting of 8-11 June 2026
(including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]2 reference numbers).
PRAC recommendations to provide supplementary information are directly actionable by the concerned
marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g.
amendment of the product information) are submitted to the Committee for Medicinal Products for
Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs),
and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)
for information in the case of Nationally Authorised Products (NAPs). Thereafter, MAHs are expected to
take action according to the PRAC recommendations.
When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or
Member States.
MAHs are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of
Directive 2001/83/EC, they shall ensure that their product information is kept up to date with the
current scientific knowledge including the conclusions of the assessment and recommendations
published on the European Medicines Agency (EMA) website (currently acting as the EU medicines
webportal).
For CAPs, at the time of publication, PRAC recommendations for update of product information have
been agreed by the CHMP at their plenary meeting (22-25 June 2026) and corresponding variations
will be assessed by the CHMP.
For nationally authorised medicinal products, it is the responsibility of the National Competent
Authorities (NCAs) of the Member States to oversee that PRAC recommendations on signals are
adhered to.
Variations for CAPs are handled according to established EMA procedures. MAHs are referred to the
available guidance. Variations for NAPs (including via mutual recognition and decentralised procedures)
are handled at national level in accordance with the provisions of the Member States.
1 Expected publication date. The actual publication date can be checked on the webpage dedicated to PRAC
recommendations on safety signals.
2 The relevant EPITT reference number should be used in any communication related to a signal.
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 2/11
The timeline recommended by PRAC for submission of variations following signal assessment is
applicable to both innovator and generic medicinal products, unless otherwise specified.
For procedural aspects related to the handling of PRAC recommendations on signals (e.g. submission
requirements, contact points, etc.) please refer to the Questions and Answers on signal management.
https://www.ema.europa.eu/documents/other/questions-answers-signal-management_en.pdf
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 3/11
1. Recommendations for update of the product information3
1.1. Darolutamide – Angioedema
Authorisation procedure Centralised
EPITT No 20237
PRAC Rapporteur Jan Neuhauser (AT)
Date of adoption 11 June 2026
Recommendation
Having considered the available evidence in EudraVigilance, including the submitted cumulative review
and additional data on time to onset, the PRAC has agreed that the MAH of Nubeqa (Bayer AG) should
submit a variation within 2 months from the publication of the PRAC recommendation, to amend the
product information as described below (new text underlined):
Summary of product characteristics
4.8 Undesirable effects
Table 1
Under SOC Skin and subcutaneous tissue disorders with frequency “Not known”
Angioedema g, h
g Includes laryngeal oedema, lip swelling, swelling face, and swollen tongue
h Spontaneous reports from post-marketing experience
Package leaflet
4 Possible side effects
Other side effects that have been reported with frequency not known (cannot be estimated from the
available data):
- swelling under the skin in areas such as the face, lips, tongue and throat
1.2. Gemcitabine – Drug reaction with eosinophilia and systemic symptoms
(DRESS)
Authorisation procedure Non-centralised
EPITT No 20256
PRAC Rapporteur Jenny Jönsson (SE)
Date of adoption 11 June 2026
3 Translations in all official EU languages of the new product information adopted by PRAC are also available to MAHs on the
EMA website.
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 4/11
Recommendation
Having considered all the available evidence, including data from EudraVigilance and the literature,
including the comments received by the Marketing Authorisation Holder/s (MAH/s) of gemcitabine
(CHEPLAPHARM ARZNEIMITTEL GMBH and SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.), the
PRAC has agreed that the MAHs of all gemcitabine-containing medicinal products should submit a
variation within 2 months from the publication of the PRAC recommendation, to amend the product
information as described below (new text underlined, text to be deleted strikethrough).
Considering the already existing wording in some nationally authorised products the text may need to
be adapted by MAH/s to individual products.
Summary of product characteristics
4.4 Warning and precautions for use
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic
epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and
acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been
reported in association with gemcitabine treatment (see section 4.8). Patients should be advised of the
signs and symptoms of the severe cutaneous adverse reactions and should seek medical advice from
their physician immediately when observing any indicative signs or symptoms. and monitored closely
for skin reactions. If signs and symptoms suggestive of these reactions appear, gemcitabine should be
withdrawn immediately and an alternative treatment considered (as appropriate).
If the patient has developed a severe cutaneous adverse reaction with the use of gemcitabine,
treatment with gemcitabine must not be restarted at any time.
4.8 Undesirable effects
Tabulated list of adverse reactions
Skin and subcutaneous tissue disorders SOC: Frequency: Not known
Drug reaction with eosinophilia and systemic symptoms (DRESS)
Package leaflet
2. What you need to know before you take Gemcitabine
Warnings and precautions
Talk to your doctor before using gemcitabine if:
• you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores
after using gemcitabine.
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute
generalized exanthematous pustulosis (AGEP) have been reported in association with gemcitabine
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 5/11
treatment. Seek medical attention immediately if you notice any of the symptoms related to these
serious skin reactions described in section 4.
This medicine can cause serious skin reactions. Seek medical attention immediately if you notice any of
the symptoms related to these serious skin reactions described in section 4.
4. Possible side effects
You should contact your doctor immediately if you develop any of the following symptoms: (Note: Add
the following heading, if the existing one differs and does not adequately reflect the urgency of the
required action, ensuring it applies to all listed severe cutaneous adverse reactions: “Seek medical
attention immediately if you notice any of the following symptoms of serious skin reactions:”)
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or
drug hypersensitivity syndrome) (frequency: not known).
1.3. Valproate and related substances4 – Neurodevelopmental disorders
with paternal exposure
Authorisation procedure Non-centralised
EPITT No 20191
PRAC Rapporteur Liana Martirosyan (NL)
Date of adoption 11 June 2026
Recommendation
Taking into account the available evidence in the literature, the PRAC considers there remains
uncertainty regarding the risk of NDD after paternal exposure to valproate during the spermatogenic
risk window and therefore this remains an important potential risk. The PRAC agreed to maintain the
precautionary measures in the product information and additional risk minimisation measures. The
final report of the PASS TANGO study will be awaited before considering any major changes to the
current risk minimisation measures in place considering the inconsistent results in the currently
available studies. However, an update on the information provided in the product information is
necessary, as the current product information only describes the results of the paternal PASS whereas
other available (epidemiological) studies have shown variable results. It is considered important to
reflect this in the product information for transparency, to ensure that HCPs and patients have access
to accurate and up-to-date information, and to acknowledge the totality of available evidence on this
potential risk. The aRMM should be updated in line with the proposed PI updates.
Therefore, the PRAC has agreed that the MAHs of valproate containing products should submit a
variation within 2 months from the publication of the PRAC recommendation, to amend the product
information as described below taking into account the already existing wording in some nationally
authorised products the text needs to be adapted by MAHs to individual products (new text underlined
and in bold and deletions in strikethrough):
Summary of product characteristics
4.4 Special warnings and precautions for use
Use in male patients
4 Valproic acid, sodium valproate, valproate semisodium, valpromide
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 6/11
A retrospective observational study suggests an increased risk of neuro-developmental disorders
(NDDs) in children born to men treated with valproate in the 3 months prior to conception compared to
those born to men treated with lamotrigine or levetiracetam. However, other studies do not
suggest an increased risk of NDDs after paternal valproate exposure. Thus, available
evidence is inconsistent and the causal role of valproate is uncertain (see section 4.6).
As a precautionary measure, prescribers should inform male patients about this potential risk (see
section 4.6) and discuss the need to consider effective contraception, including for a female partner,
while using valproate and for at least 3 months after treatment discontinuation. Male patients should
not donate sperm during treatment and for at least 3 months after treatment discontinuation.
Male patients treated with valproate should be regularly reviewed by their prescriber to evaluate
whether valproate remains the most suitable treatment for the patient. For male patients planning to
conceive a child, suitable treatment alternatives should be considered and discussed with the male
patients. Individual circumstances should be evaluated in each case. It is recommended that advice
from a specialist experienced in the management of <epilepsy> <bipolar disorder> <or> <migraine>
should be sought as appropriate.
Educational materials are available for healthcare professionals and male patients. A patient guide
should be provided to male patients using valproate.
4.6 Fertility, pregnancy and lactation
Males and potential risk of neuro-developmental disorders in children of fathers treated with valproate
in the 3 months prior to conception
A retrospective observational study in 3 Nordic countries suggests an increased risk of neuro-
developmental disorders (NDDs) in children (from 0 to 11 years old) born to men treated with
valproate as monotherapy in the 3 months prior to conception compared to those born to men treated
with lamotrigine or levetiracetam as monotherapy, with a pooled adjusted hazard ratio (HR) of 1.50
(95% CI: 1.09-2.07). The adjusted cumulative risk of NDDs ranged between 4.0% to 5.6% in the
valproate group versus between 2.3% to 3.2% in the composite lamotrigine/levetiracetam group. The
study was not large enough to investigate associations with specific NDD subtypes and study
limitations included potential confounding by indication and differences in follow-up time between
exposure groups. The mean follow-up time of children in the valproate group ranged between 5.0 and
9.2 years compared to 4.8 and 6.6 years for children in the lamotrigine/levetiracetam group. Overall
an increased risk of NDDs in children of fathers treated with valproate in the 3 months prior to
conception is possible however the causal role of valproate is not confirmed. In addition, the study did
not evaluate the risk of NDDs to children born to men stopping valproate for more than 3 months prior
to conception (i.e., allowing a new spermatogenesis without valproate exposure).
Other observational population-based studies did not show an increased risk of NDDs in
children born to men treated with valproate as monotherapy in the 3–4 months prior to
conception compared with men treated with lamotrigine or levetiracetam as monotherapy.
Differences in study design, including control for confounding and population selection, may
contribute to differences in study findings. In addition, available data suggest that factors
other than valproate exposure, including underlying paternal disease, may contribute to the
observed association. Overall, the evidence regarding an increased risk of NDDs in children
of fathers treated with valproate in the 3 months prior to conception is inconsistent, and the
causal role of valproate is uncertain.
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 7/11
As a precautionary measure, prescribers should inform male patients about this potential risk and
discuss the need to consider effective contraception, including for a female partner, while using
valproate and for at least 3 months after treatment discontinuation (see section 4.4). Male patients
should not donate sperm during treatment and for at least 3 months after treatment discontinuation.
Male patients treated with valproate should be regularly reviewed by their prescriber to evaluate
whether valproate is the most suitable treatment for the patient. For male patients planning to
conceive a child, suitable treatment alternatives should be considered and discussed with the male
patients. Individual circumstances should be evaluated in each case. It is recommended that advice
from a specialist experienced in the management of <epilepsy> <bipolar disorder> <or> <migraine>
should be sought as appropriate.
Package leaflet
2 What you need to know before you take <product name>
Important advice for male patients
Potential risks related to taking valproate in the 3 months before conception of a child
A study suggests a possible risk of movement and mental developmental disorders (problems with
early childhood development) in children born to fathers treated with valproate in the 3 months before
conception. In this study, around 5 children in 100 had such disorders when born to fathers treated
with valproate as compared to around 3 children in 100 when born to fathers treated with lamotrigine
or levetiracetam (other medicines that can be used to treat your disease). The risk for children born to
fathers who stopped valproate treatment 3 months (the time needed to form new sperm) or longer
before conception is not known. The study has limitations and therefore it is not clear if the increased
risk for movement and mental developmental disorders suggested by this study is caused by
valproate. The study has limitations and was not large enough to show which particular specific type of
movement and mental developmental disorder children may be at risk of developing.
Other studies did not suggest an increased risk of mental developmental disorders
(problems with early childhood development) in children born to fathers treated with
valproate in the 3-4 months before conception. In these studies the risk was similar
compared to children of fathers treated with lamotrigine or levetiracetam before conception.
Differences in how these studies were designed may explain the different results. Overall, it
is not known whether any possible risk of childhood developmental disorders is caused by
valproate itself or by other factors, such as the father’s underlying medical condition.
As a precautionary measure, your doctor will discuss with you:
•The potential risk in children born to fathers treated with valproate
• The need to consider effective contraception (birth control) for you and your female partner during
treatment and for 3 months after stopping treatment
• The need to consult your doctor when you are planning to conceive a child and before stopping
contraception (birth control)
• The possibility of other treatments that can be used to treat your disease, depending on your
individual situation
Do not donate sperm when taking valproate and for 3 months after stopping valproate. Talk to your
doctor if you are thinking about having a baby.
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 8/11
If your female partner becomes pregnant while you used valproate in the 3 months period before
conception and you have questions, contact your doctor. Do not stop your treatment without talking to
your doctor. If you stop your treatment, your symptoms may become worse.
You should get regular appointments with your prescriber. During this visit your doctor will discuss
with you the precautions associated with valproate use and the possibility of other treatments that can
be used to treat your disease, depending on your individual situation.
Make sure you read the patient guide that you will receive from your doctor. You will also receive a
Patient Card from your pharmacist to remind you of the potential risks of valproate.
1.4. X-ray contrast agents: iobitridol; iodixanol; iohexol; iomeprol;
iopamidol; iopromide; ioversol; ioxitalamic acid – Fixed drug eruption
Authorisation procedure Non-centralised
EPITT No 20229
PRAC Rapporteur Pernille Harg (NO)
Date of adoption 11 June 2026
Recommendation
Having considered the available evidence in EudraVigilance and the literature, including the cumulative
review submitted by the Marketing Authorisation Holders (MAHs), the PRAC has agreed that the MAHs
of products containing iomeprol, iodixanol, ioversol, iopromide, iopamidol, iohexol, iobitridol and
ioxitalamic acid should submit a variation within two months from the publication of the PRAC
recommendation, to amend the product information as described below (new text underlined):
Summary of product characteristics
4.8 Undesirable effects
Under SOC Skin and subcutaneous tissue disorders with frequency ‘Not known’
Fixed drug eruption
Package leaflet
4 Possible side effects
Under section side effects reported/described with frequency ‘Not known’ (frequency cannot be
estimated from the available data)
An allergic skin reaction that may include round or oval patches of redness and swelling of the skin,
blistering, and itching (fixed drug eruption). Darkening of the skin in affected areas, which might
persist after healing, may also occur.
Fixed drug eruption usually reoccurs at the same site(s) if the medication is <taken> <used> again.
Taking into account the already existing wording in some nationally authorised products the text may
need to be adapted by MAHs to individual products.
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 9/11
1.5. Zolbetuximab – Protein-losing gastroenteropathy
Authorisation procedure Centralised
EPITT No 20236
PRAC Rapporteur Bianca Mulder (NL)
Date of adoption 11 June 2026
Recommendation
Having considered the available evidence in EudraVigilance and literature, including the cumulative
review submitted by the Marketing Authorisation Holder (MAH), the PRAC has agreed that the MAH of
Vyloy, Astellas Pharma Europe B.V. should submit a variation within 2 months from the publication of
the PRAC recommendation, to amend the product information as described below (new text
underlined):
Summary of product characteristics
4.8 Undesirable effects
The following adverse reactions should be added under the SOC Gastrointestinal disorders:
Gastritis (frequency: uncommon)
Protein-losing gastroenteropathy (frequency: not known)
Package leaflet
4. Possible side effects
Other possible side effects:
Uncommon (may affect up to 1 in 100 people)
Inflammation of the stomach lining (gastritis)
Other side effects that have been reported with frequency not known (cannot be estimated from the
available data)
Loss of protein from the digestive tract (protein-losing gastroenteropathy)
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 10/11
2. Recommendations for submission of supplementary
information
INN Signal (EPITT No) PRAC
Rapporteur
Action for MAH MAH
Abemaciclib;
palbociclib;
ribociclib
Progressive multifocal
leukoencephalopathy
(PML) (20271)
Marie Louise
Schougaard
Christiansen
(DK)
Supplementary
information requested
(submission by 26
August 2026)
Eli Lilly
Nederland B.V.,
Novartis
Europharm
Limited, Pfizer
Europe MA EEIG
Atezolizumab;
avelumab;
cemiplimab;
dostarlimab;
durvalumab;
ipilimumab;
nivolumab;
nivolumab /
relatlimab;
pembrolizumab;
retifanlimab;
serplulimab;
sugemalimab;
tislelizumab;
toripalimab;
tremelimumab
Acquired haemophilia
(20279)
Bianca
Mulder (NL)
Supplementary
information requested
(submission by 26
August 2026)
Accord
Healthcare
S.L.U.,
AstraZeneca AB,
Beone Medicines
Ireland Limited,
Bristol-Myers
Squibb Pharma
EEIG, Cstone
Pharmaceuticals
Ireland Limited,
GlaxoSmithKline
Trading Services
Limited, Incyte
Biosciences
Distribution
B.V., Merck
Europe B.V.,
Merck Sharp &
Dohme B.V.,
Regeneron
Ireland
Designated
Activity
Company
(DAC), Roche
Registration
GmbH,
Topalliance
Biosciences
Europe Limited
Belzutifan Retinal oedema
(20278)
Dennis Lex
(DE)
Assess in the ongoing
PSUR (submission by
5 August 2026 with
the MAH comments to
the PSUR preliminary
assessment report)
Merck Sharp &
Dohme B.V.
PRAC recommendations on signals
EMA/PRAC/124080/2026 Page 11/11
INN Signal (EPITT No) PRAC
Rapporteur
Action for MAH MAH
Cefpodoxime Drug interaction
between cefpodoxime
and proton pump
inhibitor (PPIs)
resulting in a
potentially reduced
efficacy of cefpodoxime
(20280)
Amelia
Cupelli (IT)
Supplementary
information requested
(submission by 26
August 2026)
Teofarma,
Scharper SpA,
Zentiva France
Lithium Drug interaction
between lithium and
GLP-1 agonists leading
to increased lithium
levels (20275)
Dennis Lex
(DE)
Supplementary
information requested
(submission by 26
August 2026)
Teva,
Laboratoires
Delbert,
Teofarma, Oba
Pharma
Luspatercept Ventilation perfusion
mismatch (20281)
Jo Robays
(BE)
Assess in the next
PSUR (submission by
2 September 2026)
Bristol -Myers
Squibb Pharma
Osimertinib Pulmonary alveolar
haemorrhage (20284)
Bianca
Mulder (NL)
Assess in the next
PSUR (submission by
10 February 2027)
AstraZeneca AB
3. Other recommendations
INN Signal (EPITT No) PRAC
Rapporteur
Action for MAH MAH
Vortioxetine Acute pancreatitis
(20234)
Jo Robays
(BE)
Routine
pharmacovigilance
MAHs of
vortioxetine-
containing
products
1. Recommendations for update of the product information2F
1.1. Darolutamide – Angioedema
Recommendation
1.2. Gemcitabine – Drug reaction with eosinophilia and systemic symptoms (DRESS)
Recommendation
1.3. Valproate and related substances3F – Neurodevelopmental disorders with paternal exposure
Recommendation
1.4. X-ray contrast agents: iobitridol; iodixanol; iohexol; iomeprol; iopamidol; iopromide; ioversol; ioxitalamic acid – Fixed drug eruption
Recommendation
1.5. Zolbetuximab – Protein-losing gastroenteropathy
Recommendation
2. Recommendations for submission of supplementary information
3. Other recommendations
06.07.2026
Datei
PD
Study supporting the
monitoring of the availability
of medical devices on the EU market
Study overview and survey results of the 3rd EO survey
with data status 31 October 2025
1 July 2026
1
• This document was produced in the frame of the SC 2021 P3 03 under the DG SANTE
Framework contract (FWC SANTE/2021/OP/0002) for evaluation, impact assessment,
monitoring and other related services in relation to health and food policies.
• The information and views set out in this document are those of the author(s) and do not
necessarily reflect the official opinion of the Commission/European Health and Digital
Executive Agency. Neither the Commission/Executive Agency nor any person acting on the
Commission’s/Executive Agency’s behalf may be held responsible for the use which may be
made of the information contained therein.
• The study team has aggregated the data received from survey participants to prepare this
presentation but cannot be held responsible for the quality and accuracy of the data.
2
Disclaimer
1. Introduction
1.1. About the study
1.2. About the 3rd EO survey with manufacturers and authorised representatives
(incl. methodology)
2. Results
2.1. About the survey participants (responses)
2.2. Survey results for medical devices
2.3. Survey results for in vitro diagnostic medical devices
2.4. Survey results for authorised representatives
3
Content
Please cite as: Austrian National Public Health Institute, Areté, Civic Consulting (2026). PowerPoint presentation containing a study overview and survey results of
the 3rd EO survey for the ʻStudy supporting the monitoring of availability of medical devices on the EU marketʼ. Austrian National Public Health Institute (Gesundheit
Österreich GmbH / GÖG). Commissioned by the European Commission within the EU4Health Programme (under specific contract No 2021 P3 03 with the
European Health and Digital Executive Agency, implementing framework contract No SANTE/2021/OP/0002).
MD
IVD
AR
About
4
List of abbreviations (1)
Abbreviation Meaning
AIMDD Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
AR Authorised Representative(s)
CA(s) Competent Authority / Competent Authorities
CE Conformité Européenne
COCIR The European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries
DBs Distributor(s)
DG SANTE Directorate-General for Health and Food Safety
EAAR European Association of Authorised Representatives
EC European Commission
EEN European Enterprise Network
EMDN European Medical Device Nomenclature
EO Economic Operators
EU European Union
EUDAMED European Database on Medical Devices
EUROM VI Association for Medical Technology within the European Federation of Precision Mechanical and Optical Industries
FWC Framework contract
GÖG Gesundheit Österreich GmbH / Austrian National Public Health Institute
HaDEA European Health and Digital Executive Agency
5
List of abbreviations (2)
Abbreviation Meaning
IMs Importer(s)
IVDs In-vitro diagnostic medical device(s)
IVDD Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices
IVDR Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 (In Vitro Diagnostic Medical Device Regulation)
MDCG Medical Device Coordination Group
MDs Medical device(s)
MDD Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
MDR Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (Medical Device Regulation)
MFs Manufacturer(s)
NBs Notified body / bodies
OBL Own brand labelling
OEM Original equipment manufacturer
PPE Personal Protective Equipment
PPT MS Power Point
Q Question
QMS Quality Management System
SC Special contract
SMCS Single Market Compliance Space
SMEs Small and medium-sized enterprise(s)
TF Task Force
1. Introduction
6
7
1.1. About the study
- Study supporting the monitoring of availability of medical devices on the EU market
- Scope of the study
- Consultation activities
- Links to relevant documents in the context of this study
• Commissioned by: The European Commission’s Directorate-General for Health and Food
Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA)
• Aim: To support monitoring and analysing the availability of medical devices on the EU market
in the context of the implementation of medical devices and in vitro diagnostic medical devices
Regulations from the perspectives of key stakeholders
• Duration: 2 December 2022 – 1 June 2026 (42 months*)
• Study team (contact: medical.devices@goeg.at):
Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG) project lead
Areté
Civic Consulting
Supported by experts from the medical devices sector
8
Study supporting the monitoring of availability of
medical devices on the EU market
About
* Study amendment from 2 December 2025 – 1 June 2026
mailto:medical.devices@goeg.at
• Product scope:
• Product types: medical devices (MDs) and in vitro diagnostic medical devices (IVDs)
• Market status: devices placed on the market (available under the new regulations) and
those intended to be placed on the market in future (not yet available under the new
regulations) and also taking into account legacy and new devices
• Risk classes: devices belonging to all risk classes, but with a focus on devices requiring
the involvement of notified bodies
• Focus will be set on special product groups (e.g. orphan and/or niche devices) and those
at risk of shortage.
• Geographic scope: 31 countries (27 EU Member States plus Iceland, Liechtenstein,
Norway and Turkey)
9
Scope of the study
10
Consultation activities
Surveys
MDCG Taskforce Meetings
Interviews
Results are presented in
aggregated form in a publicly available and
regularly updated dashboard
Published here:
https://health.ec.europa.eu/study-supporting-monitoring-
availability-medical-devices-eu-market_en.
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
• One-pager about the study
• Endorsement letter
• Study-related glossary
• Dashboard
• Instructions for use for the dashboard
• Privacy statement
11
Links to relevant documents
in the context of this study
https://ppri.goeg.at/system/files/inline-files/One-pager_long_version_MD_availability_study_HADEA2021P303_31.5.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/One-pager_long_version_MD_availability_study_HADEA2021P303_31.5.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/One-pager_long_version_MD_availability_study_HADEA2021P303_31.5.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/One-pager_long_version_MD_availability_study_HADEA2021P303_31.5.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/One-pager_long_version_MD_availability_study_HADEA2021P303_31.5.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/One-pager_long_version_MD_availability_study_HADEA2021P303_31.5.2023_final.pdf
https://dory.goeg.at/s/yiKW72y8acdfrck
https://dory.goeg.at/s/yiKW72y8acdfrck
https://dory.goeg.at/s/yiKW72y8acdfrck
https://ppri.goeg.at/system/files/inline-files/MD_Availability_Glossary_HaDEA_2021_P3_03_April_2023.pdf
https://ppri.goeg.at/system/files/inline-files/MD_Availability_Glossary_HaDEA_2021_P3_03_April_2023.pdf
https://ppri.goeg.at/system/files/inline-files/MD_Availability_Glossary_HaDEA_2021_P3_03_April_2023.pdf
https://ppri.goeg.at/system/files/inline-files/MD_Availability_Glossary_HaDEA_2021_P3_03_April_2023.pdf
https://ppri.goeg.at/system/files/inline-files/MD_Availability_Glossary_HaDEA_2021_P3_03_April_2023.pdf
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en
https://ppri.goeg.at/system/files/inline-files/Instructions_for_Use_HaDEA-2021-P3-03_17.11.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/Instructions_for_Use_HaDEA-2021-P3-03_17.11.2023_final.pdf
https://ppri.goeg.at/system/files/inline-files/Targeted_consultations_privacy_notice_generic_MDAvailabilityStudy_final_0.pdf
https://ppri.goeg.at/system/files/inline-files/Targeted_consultations_privacy_notice_generic_MDAvailabilityStudy_final_0.pdf
12
1.2. About the 3rd EO survey
with MF and AR
- Acknowledgements
- Survey development and management
- Survey timeline
- Survey structure and content
- Comparison of the surveys conducted with EO in the framework of the study
13
Acknowledgements
The study team would like to sincerely thank the following persons and institutions for their support in
the 3rd EO survey:
• The Directorate General for Health and Food Safety at the European Commission (DG SANTE) and
the European Health and Digital Executive Agency (HaDEA);
• Members of the MDCG TF on certification capacity monitoring;
• Experts and representatives of the following organisations for the review of a draft version of the
survey and/or dissemination of the survey link: EUROM, European Federation of high-tech industries;
European Association of Authorised Representatives (EAAR); European Trade Association
representing the medical imaging, radiotherapy, health ICT and electromedical industries (COCIR);
Enterprise Europe Network (EEN); MedTech Europe and all national associations, MedTech clusters;
• All manufacturers and authorised representatives of medical devices and in vitro diagnostic
medical devices who took part in the survey or contributed to the pilot.
• Survey development: The survey was developed by the study team in close consultation
with DG SANTE/HaDEA and the MDCG TF on certification capacity monitoring. The draft
survey was reviewed by industry representatives and piloted with different companies before
the official launch.
• Survey dissemination: The survey link was shared via the European Commission,
competent authorities for medical devices, national and European representative industry
associations and clusters, direct contacts, and social media (LinkedIn, newsletter).
Companies that participated to previous surveys were also invited.
• Survey period: The survey was launched on 15 January 2026 and closed on 19 March
2026.
14
Survey development and management
15
Survey timeline for the 3rd EO survey
(data was requested until 31 October 2025)
15 January 2026
survey launched
28 February 2026
initial deadline
19 March 2026
extended deadline
survey closed
April - May 2026
data validation
216 responses
received
213 responses
considered for the
data analysis
(3 replies were not
considered due to
double submission)
1. Background and introduction
2. Questionnaire (Q1-Q59)
2.1. ABOUT: About you and your company (Q1-Q9)
2.2. MD: Questionnaire on medical devices (Q10-Q30)
2.3. IVD: Questionnaire on in vitro diagnostic medical devices (Q31-Q54)
2.4. AR-MD/IVD: Questionnaire for authorised representatives (Q55-Q57)
2.5. Closing (Q58-Q59)
Link to the final survey (as PDF) including detailed questions
16
Survey structure and content
MD
IVD
AR
About
Abbreviations: AR = Authorised representative, IVD = in vitro diagnostic medical device, MD = medical device(s), Q = question
https://ppri.goeg.at/system/files/inline-files/MDAvailabilityStudy_3rdEOSurvey_02.03.2026_extended_deadline.pdf
1st MF/AR survey
• Data period: 31/10/2023
• Targeting manufacturers
(MF) and authorised
representatives (AR)
• 658 responses considered
for the data analysis (several
roles possible)
17
2nd EO survey
• Data period: 31/10/2024
• Targeting manufacturers (MF),
authorised representatives
(AR), importers (IM) and
distributors (DB)
• 254 responses considered for
the data analysis
3rd EO survey
• Data period: 31/10/2025
• Targeting manufacturers
(MF) and authorised
representatives (AR)
• 213 responses considered
for the data analysis (several
roles possible)
Comparison of the surveys conducted with
EO in the framework of the study
501;
68%
130;
18%
105;
14%
MF MD MF IVD AR
161;
36%
60;
14%
55;
12%
72;
16%
97; 22%
MF MD MF IVD AR IM DB
152;
64%
49;
21%
36;
15%
MF MD MF IVD AR
2. Results
Notes:
• The numbers of the questions corresponding to the questionnaire can be found at the top left of each slide (i.e., Q1 for
question 1).
18
https://ppri.goeg.at/system/files/inline-files/MDAvailabilityStudy_Final%202ndEOSurvey_18.12.2024_cleared.pdf
19
2.1. About the survey
participants (responses)
Questionnaire part 2.1. including questions 1 to 9
Note: Answers to question 1 (contact details) are not provided in this presentation.
About
No response rate available as no information on number of EO reached in total
(wide distribution of survey via various channels).
20
About
216
replies received
between
15/01/2026-
19/03/2026
3
answers excluded
as EO provided
two answers to the
survey (doublets)*
213
replies considered
for data analysis
* The newer answers were selected for data analysis.
Responses to 3rd EO survey
received and to be considered for data analysis
Country, where the company is based* (1)
21
About
Share of replies from
EO from EU/non-EU
countries
Number of replies per EU country
n = 213 MF/AR
Number of replies per non-EU country
n = 41n = 172; photo credit: pixabay.com
*In the case of a multinational company this is the
country where the headquarters is located. In case of
a reply by a subsidiary, the data provided only refers
to the subsidiary.
Q2
172;
81%
41;
19%
EU
non-EU
1
1
1
1
1
1
2
2
3
3
5
9
10
16
16
20
37
43
0 5 10 15 20 25 30 35 40 45 50
Austria
Greece
Hungary
Luxembourg
Malta
Romania
Czech Republic
Portugal
Ireland
Sweden
Denmark
Netherlands
Finland
Belgium
Italy
France
Germany
Spain
1
1
1
2
2
2
3
7
9
13
0 2 4 6 8 10 12 14
Canada
Israel
Taiwan
India
Japan
Türkiye
Switzerland
China
United Kingdom
United States of America (USA)
https://pixabay.com/de/vectors/flagge-europ%C3%A4ischen-union-eu-2313980/
In case of ʻnon-EUʼ MF: country in which the AR(s) is/are resident
(multiple choice)
22
Country, where the company is based (2) About
Notes:
• Data of 41 non-EU MFs
• Multiple choice: 3 out of 41 non-EU MFs indicated more than one
AR
Most of the ARs of the non-
EU MF that replied to the
survey are located in:
1. The Netherlands
2. Germany
3. Ireland
Q2
1
1
1
1
3
3
4
4
11
17
0 2 4 6 8 10 12 14 16 18
Spain
Estonia
Sweden
France
No AR yet
Malta
Belgium
Ireland
Germany
Netherlands
Number of indications
Registration in EUDAMED
23
About
1st MF survey: n = 658 MF/ARs
2nd EO survey: n= 254 MF/ARs
3rd EO survey: n= 213 MF/ARs
Q3
85,4%
12,2%
0,0%
2,6%
7,8%
82,7%
18,9%
28,0%
2,0%
4,7%
89,2%
16,0%
23,9%
0,5%
2,8%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Registered as a MF Registered as AR Registered as IM Not registered as MF, but AR is
registered
Not registered
%
o
fE
O
1st MF survey 2nd EO survey 3rd EO survey
Note: Some participants indicated several registrations (MF, AR, IM)
Company role
Of 213 replies received (several roles possible)
• 152 indicating acting as manufacturers (MFs) for MDs,
• 49 indicating acting as manufacturers (MFs) for IVDs,
• 36 indicating acting as authorised representatives (AR),
Note: This question led to the relevant survey(s) to be completed. Some companies indicated several
roles.
24
About
Q9
152; 64%
49; 21%
36; 15%
MF MD MF IVD AR
Size of organisation (globally) (1)
25
About
76 % of the responding
companies have less than
250 employees.
57 % represent small and
micro companies.
n = 213 companies participating in the survey
Q4
micro (1 to 9
employees);
37; 17%
small (10 to 49
employees);
85; 40%
medium (50 to
249 employees);
41; 19%
large (250 or more
employees);
50; 24%
Size of organisation (globally) (2)
26
About
*n = 36 companies
indicating to act as an
authorised representative.
Thereof 17 companies
acted as AR only.
Q4
Company size by role (several roles possible)
22; 14%
64; 42%30; 20%
36; 24%
MF MD
n = 152
micro (1 to 9
employees)
small (10 to 49
employees)
medium (50 to
249 employees)
large (250 or
more employees)
6; 12%
18; 37%
9; 18%
16; 33%
MF IVD
n = 49
micro (1 to 9
employees)
small (10 to 49
employees)
medium (50 to
249 employees)
large (250 or
more employees)
9; 25%
5; 14%
5; 14%
17; 47%
AR*
n = 36
micro (1 to 9
employees)
small (10 to 49
employees)
medium (50 to
249 employees)
large (250 or
more employees)
9; 53%4; 23%
2; 12%
2; 12%
AR only
n = 17
micro (1 to 9
employees)
small (10 to 49
employees)
medium (50 to
249 employees)
large (250 or
more employees)
18%
35%
24%
21%
2%
14%
30%
25%
31%
0%
17%
40%
19%
23%
0%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
micro (1 to 9
employees)
small (10 to 49
employees)
medium (50 to 249
employees)
large (250 or more
employees)
no information
available
1st MF survey 2nd EO survey 3rd EO survey
1st MF survey: n = 658 MF/ARs
2nd EO survey: n= 254 MF/ARs
3rd EO survey: n= 213 MF/ARs
33; 15%
180; 85%
Is your company a start-up?
Yes
No
27
Start-ups*
Q5
* For the purpose of this study, start-ups are companies or ventures that are focused on new and innovative products or services that the founders want
to bring to market
About
15% of the companies
participating in the 3rd EO
survey were start-ups
n = 213 companies participating in the survey
n = 33 start-ups participating in the survey
13; 39%
17; 52%
2;
6%
1;
3% Company size of start-ups
micro (1 to 9
employees)
small (10 to 49
employees)
medium (50 to 249
employees)
large (250 or more
employees)
28
Participation in previous survey rounds
Q6
122; 57%
40; 19%
51; 24%
Did you already answer to previous survey rounds in the
context of this study?
Yes
No
I don't know
n = 213 companies participating in the survey
Where are products available
Availability of products by market
29
About
Availability of products by continent
n = 213 EOs participating in the survey, multiple responses possible
Note: Respondents could give multiple answers.
Q7
n = 213 EOs participating in the survey
71% of the
participating EOs
indicated that their
products are
available inside and
outside the EU.
Inside and
outside the EU;
152; 71%
Inside the EU;
38; 18%
Outside the EU;
6; 3%
Products are not
available yet;
17; 8%
17
94
102
103
106
127
190
0 50 100 150 200
Products not yet available
Available in Australia
Available in Africa
Available in North America
Available in South America
Available in Asia
Available in Europe (inside and outside
EU)
5
5
5
6
7
7
8
9
9
11
12
14
14
21
23
24
24
28
33
34
52
53
0 10 20 30 40 50 60
F - DIALYSIS DEVICES
J - ACTIVE-IMPLANTABLE DEVICES
Y - DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES
B - HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES
N - NERVOUS AND MEDULLARY SYSTEMS DEVICES
S - STERILISATION DEVICES (EXCLUDING CAT. D - Z)
D - DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL…
G - GASTROINTESTINAL DEVICES
K - ENDOTHERAPY AND ELECTROSURGICAL DEVICES
T - PATIENT PROTECTIVE EQUIPMENT AND INCONTINENCE AIDS (EXCLUDING PERSONAL…
H - SUTURE DEVICES
R - RESPIRATORY AND ANAESTHESIA DEVICES
U - DEVICES FOR UROGENITAL SYSTEM
M - DEVICES FOR GENERAL AND SPECIALIST DRESSINGS
C - CARDIOCIRCULATORY SYSTEM DEVICES
A - DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION
L - REUSABLE SURGICAL INSTRUMENTS
Q - DENTAL, OPHTHALMOLOGIC AND ENT DEVICES
P - IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES
V - VARIOUS MEDICAL DEVICES
Z - MEDICAL EQUIPMENT AND RELATED ACCESSORIES, SOFTWARE AND CONSUMABLES
W - IN VITRO DIAGNOSTIC MEDICAL DEVICES
30
Optional indication by companies: Device areas (EMDN
categories) currently included in the product portfolio
(EMDN categories selected by EOs)
205 out of 213 EOs answered this question (optional response was possible), resulting in 347 EMDN category indications
Category D: ... FOR MEDICAL DEVICES
Category T: … (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE)
(for details see
next slide)
About
Q8
Total number of
EMDN category indications: 347
84%
16%
MEDICAL
DEVICES
IN VITRO
DIAGNOSTIC
MEDICAL
DEVICES
31
Optional indication by companies: IVDs (EMDN
categories) currently included in the product portfolio
(number of devices referring to catalogue numbers) Total number of
EMDN category indications: 235
About
37 out of 213 EOs answered this question (optional response was possible), resulting in 235 EMDN category indications for IVDs
Q8
5
6
6
8
9
10
10
11
11
11
11
11
12
15
15
15
18
25
26
0 5 10 15 20 25 30
W0203 - MICROBIOLOGY INSTRUMENTS (CULTURES)
W0104 - MICROBIOLOGY (CULTURE)
W0502 - DEVICES FOR SAMPLES TRANSPORT (non-generic laboratory products)
W0204 - INFECTIOUS IMMUNOLOGY INSTRUMENTS
W0207 - GENERAL PURPOSE IVD INSTRUMENTS
W0206 - SAMPLE PROCESSING SYSTEMS
W0599 - IVD GENERAL USE CONSUMABLE DEVICES – OTHER
W0202 - HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS
W0205 - NUCLEIC ACID TESTING INSTRUMENTS
W0299 - IVD INSTRUMENTS – OTHER
W0503 - DEVICES FOR SAMPLES ANALYSES (no laboratory generic products)
W0580 - IVD GENERAL USE CONSUMABLE DEVICES - OTHER ACCESSORIES
W0501 - SAMPLES COLLECTION DEVICES
W0101 - CLINICAL CHEMISTRY
W0103 - HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY /…
W0106 - GENETIC TESTING
W0201 - CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS
W0102 - IMMUNOCHEMISTRY (IMMUNOLOGY)
W0105 - INFECTIOUS DISEASES
EM
D
N
c
at
eg
or
y
102; 44%
83; 35%
50; 21%
IVDs by subcategories
W01 REAGENTS
W02 IVD
INSTRUMENTS
W05 IVD GENERIC
USE
CONSUMABLES
32
2.2. Survey results
for medical devices
MD
Questionnaire part 2.2. including questions 10 to 30
33
Overview on applications and certificates by
end of October 2025 MD
Number of applications
lodged under MDR: 1319*
Number of certificates
issued for MDs under
MDR: 772
Note: These figures relate to the 152 responses from the manufacturers of MDs as of the end of October 2025.
No. of applications: data of 152 MD MF
No. of certificates: data of 87 MD MF
The total number of applications lodged also includes applications with issued certificates, ongoing applications and applications that were eventually
refused. Please, note that applications lodged for changes of existing MDR certificates are included as well.
* Even though the questions were asked in the same way to MF and NBs, the MF might have a different interpretation of applications as NBs.
** The data shown comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set
Ⓢ since they could not provide the data per Annex.
18th NB survey
(covering the same data period as the
3rd EO survey until 31/10/2025):
: 33107**
(MF sample: 4% were
potentially covered in this
survey)
17.507
(MF sample: 4% were
potentially covered in this
survey)
Q14
Q17
34
AIMDD/MDD
legacy devices*
MD
* In line with MDCG 2021-252 ‘legacy devices’ should be understood as devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after
the MDR’s date of application (i.e. 26 May 2021) if certain conditions are fulfilled.
20747
134018
0 40000 80000 120000 160000
of which number of MDD devices foreseen for up-
classification and transition to MDR with NB
intervention required for the first time
Number of AIMDD/MDD devices placed on the market
by end of October 2025
35
MDAIMDD/MDD overview by the end of
October 2025
(number of devices referring to catalogue numbers)
Notes:
1 Data of 152 MFs, including 43 MFs with the indication ʻ0ʼ;
2 Data of 152 MFs, including 96 MFs with the indication ʻ0ʼ;
Total responses from
MFs for MDs: 152
Q10
1
2
= 15% intended to transition to MDR will be up-classified.
36
MD
AIMDD/MDD overview by the end of
October 2025
Total responses from MFs for MDs: 152
Total no of valid MDD/AIMDD certificates indicated by NBs
(by end of April 2022): 25034
Notes:
3rd EO survey: Data of 152 MFs, including 49 MFs with the indication ʻ0ʼ
2nd EO survey: Data of 161 MFs, including 43 MFs with the indication ʻ0ʼ
Q11
Total number of EC certificates issued in accordance with Directive 90/385/EEC
(AIMDD) or Directive 93/42/EEC (MDD) prior to 26 May 2021 benefitting of the extended
transitional period provided for in Article 120 MDR (QMS + product certificates): 2736
(for comparison, value of the 2nd EO survey: 1168)
37
Notified bodies
written agreements, refused applications
MD
123
13 10 6
81%
9% 7% 4%0
20
40
60
80
100
120
140
Yes, for all devices Yes, for some
devices
No written
agreement signed
Not applicable
38
MDWritten agreements between MFs
of MDs with Notified Bodies
Number of companies with written agreements with a notified
body/notified bodies designated under the MDR by the end of
October 2025
Total
responses
from 152 MFs
for MDs
Note: Replies of 152 MD MFs
12%
12% 13%
Almost all of the companies have one or more
written agreements with one or several NBs:
• 90% of the MF have (a) written
agreement(s) with NBs
(2024: 90%, 2023: 67%)
• 7% of the MF that need a written agreement
don’t have one (2024: 4%, 2023: 20%)
• 4% of the MF don’t need a NB involvement
(2024: 6%, 2023: 13%)
(In brackets the results of the 1st MF/AR survey (2023)
and 2nd EO survey (2024) – replies of 501 and 161
MFs for MD respectively.)
Q12
If yes, written agreements for:
• Only legacy devices: 69
• Legacy and "new“* devices: 42
• Only new* devices: 25
*devices which have never been CE-marked but will need CE-marking under the MDR to access the EU market.
Reasons: e.g. products
were upgraded to MDR (2),
not needed (3), in process
(3), looking for a NB (1)
39
MDRefusal of applications by
Notified Bodies (1)
Did a notified body refuse
an application under the
MDR? (n=152)
Time from application to refusal
(for MD MF indicating ‘Yes, application(s)
refused.’) (n=3)
Q13
3; 2%
10; 7%
131; 86%
8; 5%
Yes, application(s) refused
No, as no application lodged yet
No, as no application refused
not applicable
2
0
1
0 0
0
1
2
3
less than 6
months
6-12 months 13-18 months 19-24 months more than 24
months
N
um
be
r o
f M
D
M
F
in
di
ca
tin
g
re
fu
se
d
ap
pl
ic
at
io
ns
2
1
0 0 0
1
0
1
2
3
Insufficient notified
body resources
Application deemed
incomplete
Wrong qualification of
product/classification of
device
Wrong conformity
assessment procedure
Outside the scope of
the notified body's
designation
Other
N
um
be
r o
fr
ef
us
ed
ap
pl
ic
at
io
ns
40
MDRefusal of applications by
Notified Bodies (2)
Number of refused applications by reason for refusal
(n=3 companies reporting 4 refused applications)
Other reasons:
Several NBs did not
answer
Comments: failure to have a thorough CEP
and CER, failure to employ competent experts
for CEP and CER, failure to provide sufficient
evidence supporting claims and intended use.
Q13
Refusals for:
• Legacy devices: 1
• New* devices: 2
*devices which have never been CE-
marked but will need CE-marking under
the MDR to access the EU market.
41
MDR implementation
applications, certificates, re-certification,
time periods
MD
42
Applications lodged under MDR
by end October 2025
MD
Number of applications lodged (total and for changes) under MDR to NBs by Annex*
Note: This number also includes applications with issued certificates, ongoing applications and applications that were ultimately refused. Please note that
applications lodged for changes to existing MDR certificates are included as well and were asked to be indicated separately. Pre-application activities are
not included. One application may cover several Annexes.
Total number of applications: 1319
(thereof 779 (59%) applications for change)
For comparison data of the 18th NB survey
(covering the same data period until 31/10/2025):
Total number of applications filed by Annex : 33.107**
* Even though the questions were asked in the same way to
MF/AR and NBs, data provided by MF seems not directly
comparable with data provided by NB as they might interpret
what an “application lodged” is in different ways.
** The data shown comes from the medium data set – 3
NBs could not provide the data per Annex.
18th NB survey: replies by 51 MDR designated NBs (=100%
response rate)
Thereof no. of applications (all
Annexes) covering new devices
(devices which have never been
CE-marked but will need CE-
marking under the MDR to access
the EU market – e.g. new devices,
devices being up-classified,
Annex XVI devices): 123 (9%)
Q14
Total
responses
from 152 MFs
for MDs
692 589 10 28 0
18734
9485
27
2238
12
0
2000
4000
6000
8000
10000
12000
14000
16000
18000
20000
Annex IX(I&III) Annex IX(II) Annex X Annex XI(A) Annex XI(B)
N
o.
o
f a
pp
lic
at
io
ns
lo
dg
ed
3rd EO survey survey 18th NB survey**
43
Applications lodged and certificates issued under MDR
by end October 2025 for MD requiring consultation
MD
Number of applications and certificates for Annex IX(II) products
requiring consultation
Note: Responses from 152 MFs for MDs.
Q14
44 1 4 29 1 2
959
13
141
319
9 0
0
200
400
600
800
1000
1200
For devices
incorporating
medicinal substance
For tissues or cells of
human origin or their
derivates
For devices based on
substances or
combination of
substances
For devices
incorporating
medicinal substance
For tissues or cells of
human origin or their
derivates
For devices based on
substances or
combination of
substances
Applications filed requiring consultation procedure Thereof certificates issued
N
um
be
r
3rd EO survey survey 18th NB survey
44
MD undergoing MDR conformity
assessment by October 2025
MD
Total number of devices (by catalogue number) undergoing MDR
conformity assessment (accepted MDR applications still under review
by NB) by the end of October 2025: 78055
(Data of 152 MFs, including 46 MFs with the indication ʻ0ʼ)
By risk class:
Q15
Class Ir/s/m
19%
Class IIa
40%
Class IIb
35%
Class III
6%
Not specified
0,1%
45
Certificates issued to MD MF under MDR
MD
Have you already received certificates under
the MDR to date up to 31/10/2025 (n=152)?
Q16
Total
responses
from 152 MFs
for MDs
Yes; 73;
45%
No; 81;
50%
No
answer;
7; 5%
Yes; 87; 57%
No; 65; 43%
For comparison the results of the 2nd EO survey –
replies of 161 MFs for MD, 31/10/2024
295 462 2 11 2
10083
6299
6
1096
23
0
2000
4000
6000
8000
10000
12000
Annex IX(I+III) Annex IX(II) Annex X Annex XI(A) Annex XI(B)
N
um
be
r o
f c
er
tif
ic
at
es
3rd EO survey survey 18th NB survey**
46
Certificates issued to MD MF under MDR
MD
Number of certificates issued to MF for MDs
under MDR by Annex by end October 2025
Total number of certificates: 772
For comparison data of the 18th NB survey
(covering the same data period until 31/10/2025):
17.507*
* The indicated no. of certificates by manufacturers is not
directly comparable to the no. of certificates indicated by NBs
since they might have a different understanding in counting
(one certificate for each product group vs. one certificate for
similar product groups).
Q17
No. of certificates: data of 87 MD MF
47
Device numbers (as per catalogue number)
covered in MDR certificates
MD
Number of devices (catalogue
numbers) covered in MDR
certificates issued by end of
October 2025: 49.671
of which new devices1: 3121 (6%)
- novel devices2: 16
- break-through devices3: 4
Note: n=86 MF
1 Devices which have never been CE-marked before but will need CE-marking under the MDR to access the EU market
2 When assessing novelty, relevant dimensions of a device in which novelty and innovation can be manifest may include, but are not limited to the
ones listed: procedure-related items, device-related items. Novelty in this context typically means that there is a lack of experience in regard to the
safety and performance of the device or specific features of the device or related clinical procedure, and there are no similar devices or insufficient
experience with similar devices to enable straightforward appraisal of its future real-world safety and performance. For more information see definition
in the Commission guidance in section 2.1: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0807(01)&rid=5on see
definition in the Commission guidance in section 2.1: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0807(01)&rid=5
3 Based on the MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746, a MD or IVD will be considered a
breakthrough device if it meets each of the following criteria:
1. Novelty: The device introduces a high degree of novelty with respect to the device technology, the related clinical procedure, and/or the application
of the device in clinical practice,
AND
2. Positive clinical impact: The device is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or
irreversibly debilitating disease or condition, by either of the following:
o Offering a significant positive clinical impact on patients or public health compared to available alternatives and the state of the art, OR
o Fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.
For more information see MDCG 2025-9: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-
2b347bd14809_en?filename=mdcg_2025-9.pdf No dedicated breakthrough pathway available under MDR
Q18
By risk class:
Class Ir;
7920; 16%
Class Is;
2154; 4%
Class Im;
31; 0%
Class IIa;
11140; 22%
Class IIb;
12016; 24%
Class III;
10645; 22%
Not specified;
5765; 12%
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0807(01)&rid=5
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0807(01)&rid=5
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0807(01)&rid=5
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0807(01)&rid=5
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0807(01)&rid=5
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
14%
43%
21%
13%
8%
19%
31%
26%
12% 11%
16%
44%
17%
12% 10%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Less than 6 months 6-12 months 13-18 months 19-24 months More than 24 months
1st MF survey 2nd EO survey 3rd EO survey
48
Time periods (1) MD
Average time to prepare an application for MDR (before submission to a
NB) – comparison of 3rd EO survey with previous surveys
Note:
• 1st MF survey: Replies of 396 MD MFs, 105 MFs indicated ʻno information availableʼ
• 2nd EO survey: Replies of 150 MD MFs, 11 MFs indicated ʻno information availableʼ
• 3rd EO survey: Replies of 144 MD MFs, 8 MFs indicated ʻno information availableʼ
14%
21%
8%
Q19
For 44% of the MD MFs it
takes 6-12 months to prepare
an application for MDR.
15%
23%
26%
18%
12%
5%4%
15%
22%
16% 18%
24%
0%
5%
10%
15%
20%
25%
30%
1-2 weeks 3-4 weeks >1 to 2 months >2 to 3 months >3 to 6 months >6 months
Pe
rc
en
ta
ge
of
N
Bs
/M
Fs
in
di
ca
tin
g
av
er
ag
e
tim
ef
ra
m
e
18th NB survey 3rd EO survey
49
Q20
Time periods (2)
Average timeframe between application lodged and written agreement
signed – comparison of 3rd EO survey with 18th NB survey
MD
Notes:
• 18th NB survey: Replies of 51 NBs designated under MDR; data collection method: NBs indicated the number of files for each category which was converted into
percent per category
• 3rd EO survey: Replies of 152 MD MFs; data collection method: EOs selected one time period
For 38% of the companies, it takes
1 to 3 months between application
lodged and written agreement
signed.
For 42 % of the companies, it takes
more than 3 months between
application lodged and written
agreement signed.
50
Time periods (3) MD
Average time to reach/issue MDR certification for devices
(from written agreement signed to issuance) – comparison of 3rd EO survey with 18th NB survey
Notes QMS certificates:
• 18th NB survey: QMS: Data of 46 NBs designated under MDR
(covering the same data period until 31/10/2025)
• 3rd EO survey: Data of 102 MD MFs; 50 MFs indicated ʻno information
availableʼ
21%
13%
Q21
Notes QMS and product certificates:
• 18th NB survey: QMS+PRODUCT: Data of 36 NBs designated under
MDR (covering the same data period until 31/10/2025)
• 3rd EO survey: Data of 108 MD MFs; 44 MFs indicated ʻno information
availableʼ
59% of the NBs indicated 13-18 months.
25% of the MD MFs indicated 13-18 months.
53% of the NBs indicated 13-18 months.
54% of the MD MFs indicated more than 19 months.
Total responses from 152 MFs for MDs
2%
33%
59%
4% 2%
9%
23% 25%
20%
25%
0%
10%
20%
30%
40%
50%
60%
70%
<6 months 6-12
months
13-18
months
19-24
months
>24
months
R
ep
lie
s
in
%
Time to reach a MDR QMS certificate
18th NB survey 3rd EO survey
0%
11%
53%
28%
8%6%
18% 21% 21%
33%
0%
10%
20%
30%
40%
50%
60%
<6 months 6-12
months
13-18
months
19-24
months
>24
months
R
ep
lie
s
in
%
Time to reach a MDR QMS and product
certificate
18th NB survey 3rd EO survey
51
Compliance with deadlines
MD
Q22
In general, do you comply with the deadlines agreed with your NB(s) for submitting data /
information and subsequent further requests?
If not:
• Lack of ressources (3)
• More time needed (3)
• Timlines are challenging (1)
• Dozens of documentations have to be rewritten again
and again, also during the application period (1)
• No timeline established (1)
• Timeline unclear (1)
• Legacy devices on the market for more than 30 years -
difficult to find clinical assessments (1)
• Delay by NBs (1)
I don't
know; 18;
12% No; 12;
8%
Yes; 122;
80%
52
Costs
MD
17883
22683
42000
24667
32774
50697
75007 77446
10000
20000 20000
14750
20000
40000
28500
50000
0
10000
20000
30000
40000
50000
60000
70000
80000
90000
Class I Class Is Class Im Class Ir Class IIa Class IIb Class IIb impl. Class III
Average Median
53
Costs for drawing up the clinical evaluation
MD
Total cost in Euro of the last single device certified
Notes: It is possible that MD MF have interpreted this question differently. Some MD MF provided ‚zero‘ as the questionnaire asked to do so, if no information is
available. For this reason ‚zeros‘ are exluded (with the risk of overestimation). Outliers below 1000 Euros and above 1000000 were excluded.
MAX:
86,000
MIN:
1,000
Q27
MAX:
86,000
MIN:
2,500
MAX:
86,000
MIN:
20,000
MAX:
86,000
MIN:
2,500
MAX:
197,690
MIN:
5,000
MAX:
155,000
MIN:
1,500
MAX:
300,000
MIN:
5,000
MAX:
300,000
MIN:
9,000
Data from 15 MF 14MF 3MF 6MF 37MF 23MF 13MF 19MF
88867
56872
40694
29343
89600
35909
50000
32500 30000
22350
65500
30000
0
10000
20000
30000
40000
50000
60000
70000
80000
90000
100000
total cost for initial
certificate
cost for NB fees per
certificate
yearly maintenance
cost per certificate
yearly maintenance
cost for NBs per
certificate
average cost for one
renewed certificate
cost for NB fees per
renewed certificate
Average Median
54
Costs for MDR certification
MD
Estimate direct average cost per already issued QMS certificate in Euro
Notes: It is possible that MD MF have interpreted this question differently. Some MD MF provided ‚zero‘ as the questionnaire asked to do so, if no information is
available. For this reason ‚zeros‘ are exluded (with the risk of overestimation). Outliers below 1000 Euros and above 1000000 were excluded.
MAX: 325,000
MIN: 5,000
MAX: 650,000
MIN: 5,000
MAX: 200,000
MIN: 1,000
MAX: 110,000
MIN: 1,700
Q28
MAX: 325,000
MIN: 17,000
MAX: 100,000
MIN: 4,000
Data from 52 MF 54 MF 54 MF 54 MF 10 MF 11 MF
194785
83782
46264
26113
159400
57800
100000
50000
30000 20000 22000 22000
0
50000
100000
150000
200000
250000
total cost for initial
certificate
cost for NB fees per
certificate
yearly maintenance
cost per certificate
yearly maintenance
cost for NBs per
certificate
average cost for one
renewed certificate
cost for NB fees per
renewed certificate
Average Median
55
Costs for MDR certification
MD
Estimate direct average cost per already issued product certificate in Euro
Notes: It is possible that MD MF have interpreted this question differently. Some MD MF provided ‚zero‘ as the questionnaire asked to do so, if no
information is available. For this reason ‚zeros‘ are exluded (with the risk of overestimation). Outliers below 900 Euros and above 10000000 were
excluded.
MAX: 1,300,000
MIN: 15,000
MAX: 455,000
MIN: 1,500
MAX: 215,500
MIN: 1,000
MAX: 100,000
MIN: 900
Q28
MAX: 663,000
MIN: 17,000
MAX: 180,000
MIN: 17,000
Data from 46 MF 46 MF 43 MF 41 MF 5 MF 5 MF
56
Estimates
Completed transition
MD
57
Completed transition
Estimate percentage of product portfolio foreseen for
transition already having MDR certification (n=152)
MD
Total responses from
152 MFs for MDs
Q29
57%
3% 2% 3% 4% 3% 1% 2% 1%
22%
50%
2% 4% 4% 4% 3% 3% 4% 3%
22%
38%
3% 5%
2% 1%
5% 4% 3% 4%
35%
0%
10%
20%
30%
40%
50%
60%
70%
≤10% 11-20% 21-30% 31-40% 41-50% 51-60% 61-70% 71-80% 81-90% 91-100%
Pe
rc
en
ta
ge
o
f M
D
M
F
in
di
ca
tin
g
es
tim
at
e
pe
rc
en
ta
ge
1st MF survey 2nd EO survey 3rd EO survey
58
Discontinuation of medical devices
MD
59
Discontinuation of medical devices (1)
Have you stopped the production/marketing/supply of some
devices to the EU market since 2021? (n=152)
MD
Q30
If yes, 7% of the MFs (5/73)
indicated that orphan/niche
devices* or orphan indications
were affected.
*According to the MDCG 2024-10 document on clinical evaluation of orphan medical
devices, a medical device or an accessory for a medical device should be regarded as
‘orphan device’, if it meets the following criteria: the device is specifically intended to
benefit patients in the treatment, diagnosis, or prevention of a disease or condition that
presents in not more than 12,000 individuals in the European Union per year; and at least
one of the following criteria are met: there is insufficiency of available alternative options for
the treatment, diagnosis, or prevention of this disease/condition, or the device will offer an
option that will provide an expected clinical benefit compared to available alternatives or
state of the art for the treatment, diagnosis, or prevention of this disease/condition, taking
into account both device and patient population specific factors.
Yes; 73;
48%No; 79;
52%
https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
1
1
2
2
3
5
14
16
19
37
46
0 5 10 15 20 25 30 35 40 45 50
Manufacturer recalls or safety concerns
Decisions/recommendations by national competent authorities
Lack of raw materials and/or components
Disruptions in the supply chain / Supplier has stopped production
Increased production costs
Other
Products at the end of their life cycle
Devices will be replaced by updated/new products
Products with low profitability
Products with low sales volumes
Product revenue does not justify cost to reapprove device under the MDR
60
Discontinuation of medical devices (2)
MD
Main reasons for product discontinuation
Notes: Number of mentions by 73 MFs having discontinued some products,
i.e. having answered question on previous slide with YES. Multiple answers per MF possible;
Q30
ʻOtherʼ reasons mentioned were:
• Costs of the NB too high
• Not sufficient amount of clinical data available on the Class III
device itself in all combinations of indications, patient groups
and operation types. The requirement was unproportional
comparing to the cost of clinical post market studies and the
revenues created from products such as bioabsorbable
orthopaedic fixation screws and plates.
• Put a small volume of devices on the EU market after initial
approval under MDD. Stopped placing these on the market to
focus company resources on placing devices on the US market
instead.
• Up-classification to Class III because of new MDR classification
rules
63% of the MFs
indicated this
as one of the
main reasons.
61
Discontinuation of medical devices (3)
MD
Q30
Types of MDs
(by EDMN
code)
discontinued
Notes: Number of mentions by 73 MFs having discontinued some products, i.e. having answered question 30 with YES. Multiple answers per MF were possible.
Several answers had to be disregarded due to unclear EMDN code.
Category T: … (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE)
Category D: …. FOR MEDICAL DEVICES
1
1
1
1
2
3
3
4
6
6
7
8
11
23
0 5 10 15 20 25
D - DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR…
J - ACTIVE-IMPLANTABLE DEVICES
R - RESPIRATORY AND ANAESTHESIA DEVICES
T - PATIENT PROTECTIVE EQUIPMENT AND INCONTINENCE AIDS (EXCLUDING…
B - HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES
M - DEVICES FOR GENERAL AND SPECIALIST DRESSINGS
U - DEVICES FOR UROGENITAL SYSTEM
L - REUSABLE SURGICAL INSTRUMENTS
C - CARDIOCIRCULATORY SYSTEM DEVICES
Q - DENTAL, OPHTHALMOLOGIC AND ENT DEVICES
V - VARIOUS MEDICAL DEVICES
A - DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION
P - IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES
Z - MEDICAL EQUIPMENT AND RELATED ACCESSORIES, SOFTWARE AND CONSUMABLES
62
Re-certification
MD
Did you already have a certificate renewed under the MDR? (n=87) out of
152 companies that answered YES to Q16)
63
Re-certification (1)
Q16.1
MD
Yes; 22;
25%
No; 65;
75%
64
Re-certification (2)
Q24
MD
Number of certificates expiring and due for re-certification in
2026-2029 (n=22 companies that answered YES to Q16.1)
29
37
56
46
9
15
10 12
0
10
20
30
40
50
60
2026 2027 2028 2029
N
um
be
r o
f c
er
tif
ic
at
es
EU technical documentation assessment (TDA) certificate MDR QMS certificates
65
Re-certification (3)
Q25
MD
On average, when do you need to submit the information for re-
certification with the NB (before the certificate expires) to ensure you
receive the renewal before expiration?
Note: Data of 22 MF
6%
17%
19%
33%
38%
25%
25%
25%
13%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
EU technical documentation assessment
(TDA) certificate
MDR QMS certificates
in % of companies
3 months before 6 months before 9 months before 12 months before More than 12 months before
66
Re-certification (4)
Q26
MD
What is the average time taken to reach renewal of the certificate
(from the submission to renewal)?
Note: Data of 22 MF (‘no information available’ was indicated by 10 MF for EU TDA certificates and by 6 for MDR QMS certificates)
25%
67%
56%
25%
13%
8%
6%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
EU technical documentation assessment
(TDA) certificate
MDR QMS certificates
in % of companies
Less than 6 months 6-12 months 13-18 months More than 18 months
67
2.3. Survey results for
in vitro diagnostic medical
devices
IVD
Questionnaire part 2.3. including questions 31 to 54
Number of applications
lodged under IVDR: 1251*
Number of certificates
issued for IVDs under
IVDR: 357
68
Overview on applications and certificates by
end of October 2025 IVD
Note: These figures relate to the responses from 60 MFs of IVDs as of the end of October 2025.
No. of applications: Data of 31 IVD MF, 18 IVD MF with “0” applications.
No. of certificates: data of 24 IVD MF
The total number of applications lodged also includes applications with issued certificates, ongoing applications and applications that were
eventually refused. Please, note that applications lodged for changes of existing IVDR certificates are included as well.
* Even though the questions were asked in the same way to MF/AR and NBs, the MF might have a different interpretation as NBs.
18th NB survey
(covering the same data
period as the 3rd EO
survey until 31/10/2025):
3304
(MF sample: 38% were
potentially covered in
this survey)
2192
(MF sample: 16% were
potentially covered in
this survey)
Q35
Q38
69
IVDD legacy devices*
IVD
* In line with MDCG 2022-8, ‘legacy devices’ should be understood as IVDs, which, in accordance with the IVDR’s transitional provisions, are placed on the market or
put into service after the IVDR’s date of application (i.e. 26 May 2022) if certain conditions are fulfilled.
2790
6728
0 1000 2000 3000 4000 5000 6000 7000 8000
Of this total number, number of IVDD devices that will
need NB intervention for the first time AND are planned to
be transitioned to the IVDR and were not IVDR certified
yet**
Number of IVDD devices (by catalogue number) placed on
the market by end of October 2025*
70
IVDD overview by the end of October 2025 IVD
Notes:
* Data from 49 MFs, including 6 MFs with the indication ʻ0ʼ;
** Data from 48 MFs, including 15 MFs with the indication ʻ0ʼ;
Total responses from
MFs for IVDs: 49
= 41%
Q31
Q32
Total number of valid IVDD certificates by end of October 2025: 177
(Data from 49 MFs, including 27 MFs with the indication ʻ0ʼ)
(for comparison, value of the 2nd EO survey: 668 - Data from 60 MFs, including 23 MFs with the indication ʻ0ʼ)
71
Details on IVDD devices transition status
to IVDR
Percentage of IVDs already transferred or
planned to be transferred to IVDR
IVD
• 33% of the MFs of IVDs (16/49)
indicated that 91-100% of IVDs
have already been transferred to
IVDR
• 30 MFs (61%) reported that more
than 50% of their devices are
already transferred or are planned to
be transferred to IVDR
• 13 out of 49 MFs of IVDs (27%)
indicated that ≤ 10% are already
transferred to IVDR
Total responses from
MFs for IVDs: 49
Q31.1
Notes:
1st MF survey: Data from 130 MFs for IVDs
2nd EO survey: Data from 60 MFs for IVDs
3rd EO survey: Data from 49 MFs for IVDs
27%
6%
0%
0%
6%
2%
6%
12%
8%
33%
20%
7%
7%
3%
5%
3%
12%
5%
8%
30%
24%
4%
3%
2%
7%
3%
5%
5%
12%
35%
0% 5% 10% 15% 20% 25% 30% 35% 40%
≤10%
11-20%
21-30%
31-40%
41-50%
51-60%
61-70%
71-80%
81-90%
91-100%
%
o
f I
VD
s
(p
öa
m
m
ed
to
b
e)
tr
an
sf
er
re
d
1st MF survey 2nd EO survey 3rd EO survey
72
Notified bodies
written agreements, refused applications
IVD
73
Written agreements between MFs
of IVDs with Notified Bodies
Number of companies with written agreements with (a) NB(s) designated
under the IVDR by the end of October 2025
IVD
Total responses from
MFs for IVDs: 49
36%
12%
24%
7%
10%
• 65% of the MF have (a) written agreement(s)
with NBs (2024: 62%, 2023: 48%)
• 22% of the MF that need a written agreement
don’t have one (2024: 37%, 2023: 42%)
• 10% of the MF don’t need a NB involvement
(2024: 2%, 2023: 10%)
(in brackets the results of the 1st MF/AR survey and 2nd EO
survey – replies of 130 and 60 MFs for IVDs respectively)
Q33
Only legacy devices: 15
Legacy and "new" devices: 15
Only new devices: 2
42%
Data from 49 MFs
23
9
1
11
0
5
47%
18%
2%
22%
10%
0
5
10
15
20
25
Written
agreements for
all devices.
Written
agreements for
some devices.
Some/all
applications, no
written
agreement.
No applications,
no written
agreements.
No, waiting for
current NB to
be designated.
No NB
involvement
necessary for
devices.
Reasons mentioned: e.g., financial reasons (1), in
preparation (2), we won't transition to the IVDR (3),
waiting for April 2026 (1), we don't have UDI codes yet
(1), we are waiting to understand if our distributor
wants to proceed with the commercialization (1)
74
Refusal of applications by
Notified Bodies (1)
Did a notified body refuse
an application under the
IVDR? (n=49)
IVD
Q34
4; 8%
10; 21%
29; 59%
6; 12%
Yes
No, my company has not sent an application yet.
No, applications were not refused so far.
Not applicable
Time from application to refusal
(for IVD MF indicating ‘Yes,
application(s) refused.’) (n=4)
2 2
0 0 0
0
1
2
3
Less than 6
months
6-12 months 13-18 months 19-24 months more than 24
months
N
um
be
r o
f I
VD
M
F
w
ith
a
pp
lic
at
io
ns
75
Refusal of applications by
Notified Bodies (2)
Reasons for refusal
(n=4 companies reporting 11 refused applications)
IVD
Q34
Refusals for:
• Legacy devices: 3
• New* devices: 2
*devices which have never been CE-marked
but will need CE-marking under the MDR to
access the EU market.
4
1 1
0
3
2
0
1
2
3
4
5
Application deemed
incomplete
Wrong qualification
of
product/classification
of device
Wrong conformity
assessment
procedure
Outside the scope of
the notified body's
designation
Insufficient notified
body resources
Other
Other reason mentioned:
IFU not in accordance with
NB's taste;
Not compliant with current
state of the art per common
specification
76
IVDR implementation
applications, certificates, re-certification,
time periods
IVD
77
Applications lodged under IVDR
by end October 2025
Number of applications lodged (total and for changes)
under IVDR to NBs by Annex
Note: This number also includes applications with issued certificates, ongoing applications and applications that were ultimately refused. Please note that applications
lodged for changes to existing IVDR certificates are included as well and were asked to be indicated separately. Pre-application activities are not included. One
application may cover several Annexes
• Applications (all Annexes) for
Class D devices: 251
• Applications (all Annexes)
requiring consultation for
companion diagnostics: 21
IVD
Total number of applications: 1251
Q35
Total responses from
MFs for IVDs: 49
** For comparison data of the 18th NB survey
(covering the same data period until 31/10/2025):
Total number of applications filed by Annex : 3.304
(thereof 236 (19%) applications for change) Notes: Data of 31 IVD MF, 18 IVD MF with “0”
applications.
735
516
0 0
1525
1765
0 14
0
500
1000
1500
2000
Annex IX(I+III) Annex IX(II) Annex X Annex XI
3rd EO survey survey 18th NB survey**
78
IVDs undergoing IVDR conformity
assessment by October 2025
Total number of devices (by catalogue number) undergoing IVDR
conformity assessment (lodged IVDR applications still under review
by NB) by end of October 2025: 689
(Data of 49 MFs, including 22 MFs with the indication ʻ0ʼ)
By risk class:
IVD
Q36
Class A
Sterile;
1; 0%
Class B;
381; 55%
Class C;
76; 11%
Class D;
25; 3%
not
specified;
215; 31%
79
Certificates issued to IVD MF under IVDR
Have you already received certificates under
the IVDR to date up to 31/10/2025 (n=49)?
Q37
Total
responses
from 49 MFs
for IVDs
IVD
Yes
45%
No
55%
Yes; 24;
49%
No; 25;
51%
For comparison the results of the 2nd EO survey –
replies of 60 MFs for IVD, 31/10/2024
80
Certificates issued to IVD MF under IVDR
Number of certificates issued to MF for IVDs
under IVDR by Annex by end October 2025
IVD
Note: Replies from 24 IVD MFs
Total number of certificates: 357
**For comparison data of the 18th NB
survey (covering the same data period
until 31/10/2025): 2192
Disclaimer:
Please, note that the no. of certificates indicated by manufacturers is not
directly comparable to the no. of certificates indicated by NBs since they
might count differently. The study team has aggregated the data received
from survey participants to prepare this presentation but cannot be held
responsible for the quality and accuracy of the data.
Q38
Q39
137
220
0 0
1078 1105
0 9
0
200
400
600
800
1000
1200
Annex IX(I+III) Annex IX(II) Annex X Annex XI
3rd EO survey 18th NB survey**
81
Device numbers (as per catalogue number)
covered in IVDR certificates
Number of devices
(catalogue
numbers) covered
in IVDR certificates
issued by end of
October 2025:
3961
IVD
Note: Replies from 24 IVD MFs
Q39
By risk class:
Class A
sterile
0%
Class B
45%
Class C
25%
Class D
11%
Not
specified
19%
17%
39%
17% 15%
11%
24%
39%
12% 10%
16%
38%
33%
18%
5%
8%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Less than 6 months 6-12 months 13-18 months 19-24 months More than 24 months
1st MF survey 2nd EO survey 3rd EO survey
82
Notes:
• 1st MF survey: Replies of 99 IVD MFs, 31 MFs indicated ʻno information availableʼ
• 2nd EO survey: Replies of 51 IVD MFs, 9 MFs indicated no information availableʼ
• 3rd EO survey: Replies of 49 IVD MFs, 9 MFs indicated no information availableʼ
IVD
Q40
Time periods (1)
Average time to prepare an application for IVDR (before submission to a
NB) – comparison of 3rd EO survey with previous surveys
For 38% of the IVD MF it takes
less than 6 months to prepare
an application for IVDR.
83
Q41
Time periods (2)
Average timeframe between application lodged and written agreement
signed – comparison of 3rd EO survey with the 18th NB survey
Notes:
• 18th NB survey: Replies of 19 NBs designated under IVDR; data collection method: NBs indicated the number of files for each category which was converted into
percent per category
• 3rd EO survey: Replies of 49 IVD MFs; data collection method: EOs selected one time period
IVD
5%
32%
29%
17%
11%
6%
8%
20%
16%
18% 18% 18%
0%
5%
10%
15%
20%
25%
30%
35%
1-2 weeks 3-4 weeks >1 to 2 months >2 to 3 months >3 to 6 months >6 months
Pe
rc
en
ta
ge
o
f N
Bs
/M
Fs
in
di
ca
tin
g
av
er
ag
e
tim
ef
ra
m
e
Average timeframe
18th NB survey 3rd EO survey
84
Time periods (3)
Average time to reach/issue IVDR certification for devices
(from written agreement signed to issuance) – comparison of 3rd EO survey with the 18th NB survey
Notes QMS certificates:
• 18th NB survey: QMS: Data of 11 NBs designated under IVDR
(covering the same data period until 31/10/2025)
• 3rd EO survey: Data of 21 IVD MFs; 28 MFs indicated ʻno information
availableʼ
21%
13% 8%
Q42
Notes QMS and product certificates:
• 18th NB survey: QMS: Data of 12 NBs designated under IVDR
(covering the same data period until 31/10/2025)
• 3rd EO survey: Data of 27 IVD MFs; 22 MFs indicated ʻno information
availableʼ
91% of the NBs indicated 6-18 months.
86% of the IVD MFs indicated less than 18 months.
92% of the NBs indicated 6-18 months.
59% of the IVD MFs indicated less than 18 months.
IVD
0%
55%
36%
9%
0%
24%
29%
33%
10%
5%
0%
10%
20%
30%
40%
50%
60%
<6 months 6-12
months
13-18
months
19-24
months
>24 months
R
ep
lie
s
in
%
Time to reach an IVDR QMS certificate
18th NB survey 3rd EO survey
0%
17%
75%
8%
0%4%
11%
44%
22% 19%
0%
10%
20%
30%
40%
50%
60%
70%
80%
<6 months 6-12
months
13-18
months
19-24
months
>24
months
R
ep
lie
s
in
%
Time to reach a IVDR QMS and product
certificate
18th NB survey 3rd EO survey
85
Compliance with deadlines
IVD
Q43
In general, do you comply with the deadlines agreed with your NB(s) for submitting data /
information and subsequent further requests?
If not – e.g.:
• It takes too long even to confirm quickscan and then to
apoint reviewer. (1)
• More time needed (1)
• Sometimes the number of inquires given in the first-round
assessment was more than 50. It was impossible to reply
and make adaptations in Technical Documentations for
all the given inquires within 20 working days. (1)
No; 7; 14%
Yes; 42;
86%
86
Costs
IVD
10000
23032
123000
10000
20000
50000
0
20000
40000
60000
80000
100000
120000
140000
Class B Class C Class D
Average Median
87
Costs for drawing up the clinical evaluation
Total cost in Euro of the last single device certified
Notes: It is possible that IVD MF have interpreted this question differently. Some IVD MF provided ‚zero‘ as the questionnaire asked to do so, if no information
is available. For this reason ‚zeros‘ are exluded (with the risk of overestimation). Outliers below 1000 Euros and above 1500000 were excluded.
MAX: 10,000
MIN: 10,000
Q48
MAX: 48,516
MIN: 5,000
MAX: 1,150,000
MIN: 30,000
Data from 2 MF 9 MF 3 MF
IVD
73102
33212
40141
25385
3500 3500
60000
37320
30000
22000
3500 3500
0
10000
20000
30000
40000
50000
60000
70000
80000
total cost for initial
certificate
cost for NB fees per
certificate
yearly maintenance
cost per certificate
yearly maintenance
cost for NBs per
certificate
average cost for
one renewed
certificate
cost for NB fees per
renewed certificate
Average Median
88
Costs for IVDR certification
Estimate direct average cost per already issued QMS certificate in Euro
Notes: It is possible that MD MF have interpreted this question differently. Some MD MF provided ‚zero‘ as the questionnaire asked to do so, if no
information is available. For this reason ‚zeros‘ are exluded (with the risk of overestimation). Outliers below 1000 Euros were excluded.
MAX: 200,000
MIN: 3,500
MAX: 60,000
MIN: 3,500
MAX: 100,000
MIN: 7,000
MAX: 52,000
MIN: 5,700
Q49
MAX: 3,500
MIN: 3,500
MAX: 3,500
MIN: 3,500
Data from 17 MF 16 MF 16 MF 13 MF 1MF 1MF
IVD
50228
34011
29508
17182
7500 7500
48500
30000
20000
15000
7500 7500
0
10000
20000
30000
40000
50000
60000
total cost for initial
certificate
cost for NB fees per
certificate
yearly maintenance
cost per certificate
yearly maintenance
cost for NBs per
certificate
average cost for one
renewed certificate
cost for NB fees per
renewed certificate
Average Median
89
Costs for IVDR certification
Estimate direct average cost per already issued product certificate in Euro
Notes: It is possible that IVD MF have interpreted this question differently. Some IVD MF provided ‚zero‘ as the questionnaire asked to do so, if no
information is available. For this reason ‚zeros‘ are exluded (with the risk of overestimation). Outliers below 1000 Euros were excluded.
MAX: 150,000
MIN: 7,500
MAX: 90,000
MIN: 5,448
MAX: 100,000
MIN: 4,000
MAX: 40,000
MIN: 3000
Q49
MAX: 7,500
MIN: 7,500
MAX: 7,500
MIN: 7,500
Data from 15 MF 13 MF 14 MF 11 MF 1 MF 1 MF
IVD
90
Estimates
IVD
91
New devices
For how many new devices that were not in the IVDD portfolio do
you plan to apply for a certificate under the IVDR?
520 new devices
(in total covering all risk classes)
Note: n=49 companies including 25 with the indication ʻ0ʼ
IVD
Q50
By risk class
Class A
Sterile; 2;
0,4%
Class B; 360;
69,2%
Class C;
98; 18,8%
Class D;
26; 5,0%
not specified;
34; 6,5%
92
Discontinued in vitro diagnostic
medical devices
IVD
93
Discontinuation of IVDs (1)
Have you stopped the production/marketing/supply of
some IVDs to the EU market since 2022? (n=49)
IVD
Q51
If yes, were
orphan/niche* devices
affected?
0 MF said yes
*According to the MDCG 2024-10 document on clinical evaluation of orphan medical
devices, a medical device or an accessory for a medical device should be regarded as
‘orphan device’, if it meets the following criteria: the device is specifically intended to
benefit patients in the treatment, diagnosis, or prevention of a disease or condition that
presents in not more than 12,000 individuals in the European Union per year; and at least
one of the following criteria are met: there is insufficiency of available alternative options
for the treatment, diagnosis, or prevention of this disease/condition, or the device will
offer an option that will provide an expected clinical benefit compared to available
alternatives or state of the art for the treatment, diagnosis, or prevention of this
disease/condition, taking into account both device and patient population specific factors..
Yes; 30;
61%
No; 19; 39%
If yes, will Own Brand
Labelled devices be
affected?
9 MFs said yes
(= 30%; 9/30)
94
Discontinuation of IVDs (2)
Do you plan to discontinue some IVDs on the EU
market in the coming months? (n=49)
IVD
Q52
*According to the MDCG 2024-10 document on clinical evaluation of orphan medical
devices, a medical device or an accessory for a medical device should be regarded as
‘orphan device’, if it meets the following criteria: the device is specifically intended to
benefit patients in the treatment, diagnosis, or prevention of a disease or condition that
presents in not more than 12,000 individuals in the European Union per year; and at least
one of the following criteria are met: there is insufficiency of available alternative options
for the treatment, diagnosis, or prevention of this disease/condition, or the device will
offer an option that will provide an expected clinical benefit compared to available
alternatives or state of the art for the treatment, diagnosis, or prevention of this
disease/condition, taking into account both device and patient population specific factors.
If yes, will
orphan/niche devices
be affected?
2 MFs said yes
(= 9%; 2/22)
If yes, will Own Brand
Labelled devices be
affected?
7 MFs said yes
(= 32%; 7/22)
Yes; 22;
45%No; 27; 55%
95
Discontinuation of IVDs (3)
Types of IVDs
(by EDMN code)
stopped or for
which “stop is
already planned”
IVD
Number of mentions
Q51
Q52
Notes: 30 MFs indicated the EMDN codes for the
discontinued IVDs; 22 MF indicated the EMDN
codes for the IVDs planned to be discontinued
1
2
3
3
4
7
10
10
0
0
3
3
2
1
3
7
0 2 4 6 8 10 12
W0104 MICROBIOLOGY (CULTURE)
W05 IVD GENERIC USE CONSUMABLES
W0103 HAEMATOLOGY / HAEMOSTASIS /
IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY
W0106 GENETIC TESTING
W0101 CLINICAL CHEMISTRY
W02 IVD INSTRUMENTS
W0102 IMMUNOCHEMISTRY (IMMUNOLOGY)
W0105 INFECTIOUS DISEASES
stop is already planned stopped
0
0
0
0
0
1
2
4
6
17
19
2
2
4
3
8
14
0 2 4 6 8 10 12 14 16 18 20
Manufacturer recalls or safety concerns
Decisions/recommendations by national competent authorities
Product revenue does not justify cost to reapprove device under the IVDR.
Lack of raw materials and/or components
Disruptions in the supply chain / Supplier has stopped production
Increased production costs
Other
Products with low profitability
Products at the end of their life cycle
Devices will be replaced by updated/new products
Products with low sales volumes
planned stopped
96
Discontinuation of IVDs (4)
Reasons for MF having stopped or planning to stop production/marketing/supply of
some IVDs to the EU market
Notes: Number of mentions; Multiple answers per MF possible; 30 MFs having stopped and 22 MF planning to stop participated in this survey question.
IVD
ʻotherʼ reasons mentioned:
• No agreement with the distributor
• Manufacturer does not plan to continue in
IVD activities any more
Q64
Q63
97
Re-certification
IVD
98
Re-certification (1)
Q37.1
IVD
Did you already have a certificate renewed under the IVDR?
(n=24 out of 49 companies that answered YES to Q37)
Yes; 4; 17%
No; 20; 83%
99
Re-certification (2)
Q45
IVD
Number of certificates expiring and due for re-certification in 2026-2029
(n=24 out of 49 companies that answered YES to Q37)
Note: Data of 4 MF
29
21
27
24
3
1 2
0
0
5
10
15
20
25
30
35
2026 2027 2028 2029
N
um
be
r o
f c
er
tif
ic
at
es
EU technical documentation assessment (TDA) certificate IVDR QMS certificates
100
Re-certification (3)
Q46
IVD
On average, when do you need to submit the information for re-
certification to the NB (before the expiration of the certificate) to assure
you receive the renewal before expiration?
Note: Data of 4 MF
25%
25%
25%
25%
25%
25%
25%
25%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
EU technical documentation assessment
(TDA) certificate
IVDR QMS certificates
in % of companies
3 months before 6 months before 9 months before 12 months before More than 12 months before
101
Re-certification (4)
Q47
IVD
What is the average time taken to reach renewal of the certificate
(from the submission to renewal)?
Note: Data of 4 MF (no information available’ was indicated by 2 MF for EU TDA certificates and by 1 for IVDR QMS certificates)
50%
33%
0%
33%
50%
33%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
EU technical documentation assessment
(TDA) certificate
IVDR QMS certificates
in % of companies
Less than 6 months 6-12 months 13-18 months
102
Preparedness of manufacturers
IVD
103
Preparedness of manufacturers (1)
Do you have an IVDR-compliant QMS?
This refers to EU QMS certification under the IVDR, not under ISO 13485 accreditation.
IVD
Q53
• 1st MF survey:
Data from 118 IVD MF
• 2nd EO survey:
Data from 60 IVD MF
• 3rd EO survey:
Data from 49 IVD MF
37%
14%
21% 22%
6%
38%
22% 20%
17%
3%
47%
14%
29%
6% 4%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Yes, certified QMS
covers full portfolio
Yes, certified QMS
covers part of portfolio
Yes, QMS is IVDR
compliant but not
certified yet
No, QMS is not IVDR
compliant but IVDD
compliant
No
1st MF survey 2nd EO survey 3rd EO survey
104
Have you already transferred your products/technical
documentation to the IVDR?
Preparedness of manufacturers (2)
IVD
Q54
• 1st MF survey:
Data from 130 IVD MF
• 2nd EO survey:
Data from 60 IVD MF
• 3rd EO survey:
Data from 49 IVD MF
29%
15%
5%
18% 18% 15%
45%
15%
7%
13%
18%
2%
49%
14%
2%
14%
10% 10%
0%
10%
20%
30%
40%
50%
60%
First products
certified under
IVDR
Progressing
towards
certification under
IVDR
Applications
lodged, but
insufficient
information on
progress
No, we have not
yet submitted but
are confident that
we will get timely
certification
thereafter.
No Not applicable/no
information
1st MF survey 2nd EO survey 3rd EO survey
105
2.4. Survey results for authorised
representatives
Questionnaire part 2.4. including questions 55 to 57
AR
106
Number of authorised representatives
within the organisational structure of
a legal manufacturer
Authorised representatives (1)
Number of companies represented by
authorised representatives
AR
Total responses from
ARs: 36
Q55
Q56
AR within the
organisational
structure of a
company; 20;
56%
AR not within
the
organisational
structure of a
company; 16;
44%
3
2
4
7
20
0 5 10 15 20 25
not applicable
more than 500 clients
between 101 and 500 clients
between 10 and 100 clients
fewer than 10 clients
Number of AR
107
Estimation for legacy devices (AIMDD/MDD):
How many of your clients have completed the transition to the
MDR (all devices are CE-marked)?
Authorised representatives
Legacy devices transition
Note: 10 AR indicated ʻI don’t know / not applicableʼ.
MDAR
Total responses from
ARs: 36
Q57
1
2
6
3
3
6
8
2
0 1 2 3 4 5 6 7 8 9
Less than 25 %
25-50 %
51-75 %
More than 75 %
Number of AR
Pe
rc
en
t (
%
) o
f c
lie
nt
s
Clients have not yet started the transition Partially completed Fully completed
108
Estimation for legacy devices (IVDD):
How many of your clients have completed the transition to the
IVDR (all devices are CE-marked)?
Authorised representatives
Legacy devices transition
IVD
Note: 20 AR indicated ʻI don’t know / not applicableʼ.
AR
Total responses from
ARs: 36
Q57
2
1
2
1
8
1
4
1
0 1 2 3 4 5 6 7 8 9
Less than 25 %
25-50 %
51-75 %
More than 75 %
Number of AR
Pe
rc
en
t (
%
) o
f c
lie
nt
s
Clients have not yet started the transition Partially completed Fully completed
Thank you
Contact for questions: medical.devices@goeg.at
Austrian National Public Health Institute/ Gesundheit Österreich (GÖG)
© European Union 2026
Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that are
not owned by the EU, permission may need to be sought directly from the respective right holders.
109
mailto:medical.devices@goeg.at
https://creativecommons.org/licenses/by/4.0/
Study supporting the �monitoring of the availability�of medical devices on the EU market
Disclaimer
Content
List of abbreviations (1)
List of abbreviations (2)
1. Introduction
1.1. About the study
Study supporting the monitoring of availability of medical devices on the EU market
Scope of the study
Consultation activities
Links to relevant documents �in the context of this study
1.2. About the 3rd EO survey with MF and AR
Acknowledgements
Survey development and management
Survey timeline for the 3rd EO survey�(data was requested until 31 October 2025)
Survey structure and content
Comparison of the surveys conducted with EO in the framework of the study
2. Results
2.1. About the survey participants (responses)
Foliennummer 20
Country, where the company is based* (1)
Country, where the company is based (2)
Registration in EUDAMED
Company role
Size of organisation (globally) (1)
Size of organisation (globally) (2)
��Start-ups*
Participation in previous survey rounds
Where are products available
Optional indication by companies: Device areas (EMDN categories) currently included in the product portfolio �(EMDN categories selected by EOs)
Optional indication by companies: IVDs (EMDN categories) currently included in the product portfolio �(number of devices referring to catalogue numbers)
2.2. Survey results �for medical devices
Overview on applications and certificates by end of October 2025
AIMDD/MDD �legacy devices*
Foliennummer 35
Foliennummer 36
Notified bodies�written agreements, refused applications
Foliennummer 38
Foliennummer 39
Foliennummer 40
MDR implementation�applications, certificates, re-certification, time periods
Applications lodged under MDR �by end October 2025
Applications lodged and certificates issued under MDR by end October 2025 for MD requiring consultation
MD undergoing MDR conformity assessment by October 2025
Certificates issued to MD MF under MDR
Certificates issued to MD MF under MDR
Device numbers (as per catalogue number) covered in MDR certificates
Time periods (1)
Time periods (2)
Time periods (3)
Compliance with deadlines
Costs
Costs for drawing up the clinical evaluation
Costs for MDR certification
Costs for MDR certification
Estimates�Completed transition
Completed transition
Discontinuation of medical devices
Discontinuation of medical devices (1)
Discontinuation of medical devices (2)
Discontinuation of medical devices (3)
Re-certification
Re-certification (1)
Re-certification (2)
Re-certification (3)
Re-certification (4)
2.3. Survey results for �in vitro diagnostic medical devices
Overview on applications and certificates by end of October 2025
IVDD legacy devices*
Foliennummer 70
Foliennummer 71
Notified bodies�written agreements, refused applications
Foliennummer 73
Foliennummer 74
Foliennummer 75
IVDR implementation�applications, certificates, re-certification, time periods
Applications lodged under IVDR �by end October 2025
IVDs undergoing IVDR conformity assessment by October 2025
Certificates issued to IVD MF under IVDR
Certificates issued to IVD MF under IVDR
Device numbers (as per catalogue number) covered in IVDR certificates
Foliennummer 82
Time periods (2)
Time periods (3)
Compliance with deadlines
Costs
Costs for drawing up the clinical evaluation
Costs for IVDR certification
Costs for IVDR certification
Estimates
New devices
Discontinued in vitro diagnostic medical devices
Discontinuation of IVDs (1)
Discontinuation of IVDs (2)
Discontinuation of IVDs (3)
Discontinuation of IVDs (4)
Re-certification
Re-certification (1)
Re-certification (2)
Re-certification (3)
Re-certification (4)
Preparedness of manufacturers
Preparedness of manufacturers (1)
Foliennummer 104
2.4. Survey results for authorised representatives
Foliennummer 106
Foliennummer 107
Foliennummer 108
Thank you��Contact for questions: medical.devices@goeg.at ��Austrian National Public Health Institute/ Gesundheit Österreich (GÖG)
06.07.2026
Datei
PD
BERLIN
Friedrichstraße 134
10117 Berlin
BONN
Ubierstraße 71–73
53173 Bonn
Pharma Deutschland e. V.
info@pharmadeutschland.de
www.pharmadeutschland.de
BRÜSSEL
Rue Marie de Bourgogne 58
1000 Brüssel
Pressemitteilung
Health4EU: Europa erweitert den Blick auf
Versorgungssicherheit
Biotech Act, klinische Studien und Produktion rücken in
den Mittelpunkt
Berlin (3. Juli 2026) – Wie Europa seine Gesundheitsversorgung
widerstandsfähiger machen und gleichzeitig seine
Wettbewerbsfähigkeit im Life-Science-Sektor stärken kann, stand
im Mittelpunkt des Health4EU Presidency Talk zum Auftakt der
irischen EU-Ratspräsidentschaft in Berlin. Vertreterinnen und
Vertreter aus Politik, Wissenschaft, Industrie und europäischen
Institutionen waren sich einig: Versorgungssicherheit, Forschung
und Innovation müssen stärker gemeinsam gedacht werden.
Entsprechend will die irische Ratspräsidentschaft zentrale
Vorhaben wie den Biotech Act, den Critical Medicines Act sowie die
Weiterentwicklung klinischer Studien und des
Medizinprodukterechts voranbringen. Ziel ist es, Europa als
Forschungs-, Entwicklungs- und Produktionsstandort
wettbewerbsfähiger zu machen und Innovationen schneller in die
Versorgung zu bringen.
„Innovation only delivers value if it reaches patients“, sagte Maurice
O'Connor, Assistant Secretary im irischen Gesundheitsministerium.
Versorgungssicherheit beginne deshalb nicht erst bei stabilen
Lieferketten. Europa brauche schnellere und verlässlichere
Rahmenbedingungen für Forschung, klinische Studien, Zulassung
und Erstattung. „Security of supply is not ultimately about supply
chains. It is about whether a patient can receive the medicine they
need.“ Versorgungssicherheit bedeute dabei vor allem, dass
Patientinnen und Patienten die benötigten Arzneimittel zuverlässig
erhalten, so O’Connor.
Daran knüpfte Prof. Dr. Veronika von Messling an. Europa verfüge
bereits über exzellente Forschung. Entscheidend sei nun,
wissenschaftliche Erkenntnisse konsequenter in marktfähige
Innovationen zu überführen. Als Erfolg des Biotech Acts werde sich
2
messen lassen, ob mehr Entwicklungen den Sprung in den Proof of
Concept, in klinische Studien und schließlich in die Versorgung
schaffen. Klinische Studien seien dabei ein wichtiger Gradmesser.
Aus Sicht der Europäischen Kommission beginnt
Versorgungssicherheit noch früher. Dr. Florika Fink-Hooijer machte
deutlich, dass Investitionen in Gesundheitsinfrastruktur,
Produktionskapazitäten und medizinische Gegenmaßnahmen nicht
erst in einer Krise erfolgen dürfen. Gesundheitsbedrohungen seien
bereits Realität, entsprechend müsse Europa dauerhaft in Vorsorge
investieren und seine Produktionskapazitäten stärken. „Resilience
is not built in a crisis. It is built beforehand“, sagte Fink-Hooijer und
verwies auch auf die Fortschritte Europas bei der Krisenvorsorge
seit der COVID-19-Pandemie.
Die Diskussion zeigte damit einen gemeinsamen
Perspektivwechsel: Versorgungssicherheit wird nicht mehr
ausschließlich als Frage der Krisenvorsorge verstanden. Sie
entsteht entlang der gesamten Wertschöpfungskette von der
Forschung bis zur Versorgung der Patientinnen und Patienten.
"Die Diskussionen haben gezeigt, dass Europa
Versorgungssicherheit heute umfassender versteht als noch vor
wenigen Jahren. Entscheidend wird sein, diesen Anspruch nun
auch in konkrete Rahmenbedingungen zu übersetzen – damit
Forschung, Entwicklung, Produktion und Versorgung künftig stärker
zusammengedacht werden." so Dorothee Brakmann,
Hauptgeschäftsführerin Pharma Deutschland abschließend.
_______________
Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der
Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400
Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und
Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten
Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in
Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken
verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen
Arzneimittel sowie einen Großteil der stofflichen und dentalen
Medizinprodukte für die Patientinnen und Patienten bereit. Unter
www.pharmadeutschland.de gibt es mehr Informationen zu Pharma
Deutschland.
http://www.pharmadeutschland.de/
03.07.2026
Datei
Wie sich das GKV-Beitragssatz-
Stabilisierungs-Gesetz (BStabG) auf die
Innovationsfähigkeit der Pharmabranche
und die Arzneimittelversorgung auswirkt
Die zentralen Aspekte auf einen Blick
• Die im BStabG geplanten Sparmaßnahmen zielen hauptsächlich auf den
Patentmarkt, aber auch der Generikamarkt ist betroffen.1
• Rund 85 Prozent dieses patentgeschützten Arzneimittelmarktes entfallen auf
Arzneimittel gegen lebensbedrohliche oder schwere chronische
Erkrankungen: Krebs, schwere Autoimmun- und Entzündungserkrankungen,
Schlaganfall-Prävention und Thrombose sowie Diabetes mit
Folgeerkrankungen.2
• Die GKV-Arzneimittelausgaben lagen 2025 bei 58,49 Mrd. Euro (+5,9 % im
Vergleich zum Vorjahreszeitraum). Mit einem Anstieg der Leistungsausgaben
um 5,9% ist das Wachstum im Vergleich zu anderen Leistungsbereichen
unterdurchschnittlich. Zur Einordnung: die Leistungsausgaben stiegen um 7,9
%, Ausgaben für Krankenhausbehandlungen um 9,6 %, Ausgaben für
ambulant ärztliche Behandlungen um 7,6%.
1BMG, Finanzentwicklung GKV 2025; AOK Arzneimittel-Kompass 2025.
https://www.bundesgesundheitsministerium.de/ministerium/meldungen/finanzentwicklung-gkv-2025
2Eigene Berechnung auf Basis IQVIA-Marktbericht Q4/2025 (GKV-Gesamtmarkt 59,3 Mrd. €) und AOK Arzneimittel-Kompass 2025
(patentgeschützter Markt = 54 % der Kosten). https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-
marktbericht-classic-q4-2025.pdf
https://www.bundesgesundheitsministerium.de/ministerium/meldungen/finanzentwicklung-gkv-2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
• 3Der geplante (dynamische) Herstellerabschlag kann den Zwangsrabatt auf
innovative Arzneimittel bis 2030 auf über 20 Prozent treiben – eine
Verfünffachung der jährlichen Belastung von 1,1 auf 5,5 Mrd. Euro.4
• Die Maßnahmen wirken kumulierend. Dynamischer Herstellerabschlag,
neue Rabattverträge für patentgeschützte Arzneimittel, Preis-Mengen-
Regelungen und das verlängerte Preismoratorium treffen dieselben
Arzneimittel gleichzeitig und übereinander gelagert. Damit gefährdet nicht nur
jede Maßnahme für sich, sondern insbesondere ihr Zusammenwirken Zugang,
Therapievielfalt und Standort.5
• Die Preissenkungen wirken additiv auf bereits verhandelte Preise. Also
Preise, die im Rahmen des AMNOG-Verfahrens bereits auf der Basis von
Nutzenbewertungen gefunden wurden. Aus dieser Basis wurde mit der
Krankenkasse ein Preis verhandelt, der dem Wert des Arzneimittels für
Patienten entspricht.
• Die Pharmaindustrie ist mit einer Investitionsquote von 5,7 Prozent die
investitionsstärkste Industrie Deutschlands. Kurzfristige, kumulierende
Preiseingriffe gefährden langfristig geplante Standortinvestitionen.6
4Pharma Deutschland: Risiken des GKV-BStabG für Arzneimittelversorgung und Innovation.
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-
innovation/
5Pharma Deutschland: Inhalte des GKV-Beitragssatzstabilisierungsgesetzes.
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
6IW Köln, PharmaKompakt 2025.
https://www.iwkoeln.de/fileadmin/user_upload/Studien/Gutachten/Pharma_Standort_D/2025/PharmaKompakt_2025_DE.pdf
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
https://www.iwkoeln.de/fileadmin/user_upload/Studien/Gutachten/Pharma_Standort_D/2025/PharmaKompakt_2025_DE.pdf
Verteilung des GKV-Umsatzes nach
Erkrankungsschwere (2025)
Das GKV-BStabG belastet ausgerechnet den Marktteil am stärksten, der die
Versorgung Schwerstkranker sichert und die forschungs- und investitionsstärkste
Industrie Deutschlands trägt.7
Erkrankungskategorie Beispiel-Wirkstoffklassen (Cluster) GKV-Umsatz
2025* Anteil**
Krebserkrankungen &
Immuntherapien
MAB-Antineoplastika,
Proteinkinasehemmer,
Hormonantagonisten
~ 9,5 – 10,1
Mrd. € ~ 39 %
Schwere Autoimmun-
/Entzündungserkrankungen
Anti-TNF, Interleukin-Inhibitoren,
JAK-Inhibitoren, MS-Mittel
~ 6,8 – 7,0
Mrd. € ~ 28 %
Diabetes mit schweren
Komplikationen
SGLT2-Hemmer, GLP-1-Agonisten,
Insulin-Analoga
~ 5,0 – 5,2
Mrd. € ~ 21 %
Schlaganfall-Prävention &
Thrombose
Direkte Faktor-Xa-Hemmer
(Apixaban, Rivaroxaban, Edoxaban)
~ 2,9 – 3,0
Mrd. € ~ 12 %
Summe vier Cluster
Summe
schwere/lebensbedrohliche
Erkrankungen (vier Cluster)
~ 24,2 – 25,3
Mrd. €
~ 41 – 43
% des
GKV-
Marktes
\.GKV‗Umsatz.868❶.(IQVIA.Apothekenmarkt?.Jan Dez.868❶)¡.\\.Anteil.der.ersten.drei.Spalten.am.umsatzstarken.
Marktsegment.der.vier.Cluster.(∫ .80?8 8❶?9.Mrd¡.₭)·.die.letzte.Zeile.bezieht.den.Anteil.auf.den.GKV‗Gesamtmarkt.(❶❺?9.Mrd¡.
₭)¡.Werte.gerundet·.Schätzung.auf.Basis.der.ATC‗Gruppen.und.Hauptindikationen¡
7Eigene Berechnung auf Basis der ATC-Umsätze 2025 (IQVIA Q4/2025) der vier Versorgungscluster. Der Arzneimittel-Atlas 2025
bestätigt qualitativ, dass es sich „ganz überwiegend um Arzneimittel gegen sehr schwere bis mittelschwere Erkrankungen“ handelt.
https://www.mwv-
berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d209028
29b3955df25e0387fe2f3c1c2b.pdf
https://www.mwv-berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d20902829b3955df25e0387fe2f3c1c2b.pdf
https://www.mwv-berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d20902829b3955df25e0387fe2f3c1c2b.pdf
https://www.mwv-berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d20902829b3955df25e0387fe2f3c1c2b.pdf
Die vier Therapie-Cluster (Datenbasis 2025)
Die umsatzstärksten patentgeschützten Präparate ordnen sich vier Versorgungs-
Clustern zu. Für jedes Cluster sind Leit-Wirkstoffklassen, GKV-Umsatz 2025 und
Marktentwicklung dargestellt.
Übersicht: Cluster-Umsätze im GKV-Markt 2025
Therapie-Cluster GKV-Umsatz
2025 (Schätzung)
Anteil
Gesamtmarkt
Wachstum
vs. 2024
Leit-
Wirkstoffklassen
Onkologie &
Immuntherapien 9,5 – 10,1 Mrd. € 16 – 17 % +10 – 12 %
MAB-Antineoplastika,
Proteinkinasehemmer,
Hormonantagonisten
Autoimmun- &
entzündliche
Erkrankungen
6,8 – 7,0 Mrd. € 11,5 – 11,8 % -5 bis -8 %
Anti-TNF, Interleukin-
Inhibitoren, JAK-
Inhibitoren, MS-Mittel
Diabetes &
Stoffwechsel 5,0 – 5,2 Mrd. € 8,5 – 8,8 % +20 – 25 %
SGLT2-Hemmer,
GLP-1-Agonisten,
Insulin-Analoga
Herz-Kreislauf &
Thrombose (B01) 2,9 – 3,0 Mrd. € ~ 5,0 % +0,8 %
(B01F)
Direkte Faktor-Xa-
Hemmer, ARNI,
PCSK9-Inhibitoren
Quelle¿.IQVIA.Pharma‗Marktbericht.Q0―868❶.(Gesamtjahr.868❶?.ATC‗Gruppen)·.ergänzt.um.GAmSi.Bayern.Q7―868❶.und.
Arzneimittel‗Atlas.868❶¡.Schätzungen·.Überschneidungen.(SGLT8‗Hemmer.Diabetes―Herz‗Kreislauf).im.Text.gekennzeichnet¡.
Vier.Cluster.gesamt.∫ .80?8 8❶?9.Mrd¡.₭.(∫ .07 09.↘ .des.GKV‗Marktes)¡8
8IQVIA Pharma-Marktbericht Q4/2025; GAmSi Bayern KV71 Q1/2025; IGES Arzneimittel-Atlas 2025. https://www.iqvia.com/-
/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Cluster Onkologie & Immuntherapien
GKV-Umsatz 2025 ≈ 9,5 – 10,1 Mrd. € (L01G 4.327 Mio. € +5,8 %; L01H 3.298 Mio. €
+14,0 %; L02B 1.502 Mio. €)
Versorgte Indikationen
Diverse Krebserkrankungen: nicht-kleinzelliges Lungenkarzinom,
Melanom, multiples Myelom, chronische lymphatische Leukämie,
Mammakarzinom, Prostatakarzinom u. v. m.
Leitpräparate
(Wirkstoffklassen)
PD-1/PD-L1-Inhibitoren (Checkpoint-Inhibition), Proteinkinasehemmer
(CDK-, BTK-Inhibitoren), CD38-Antikörper, EGFR-Inhibitoren,
zytostatische Hormonantagonisten
Investitionsschwerpunkt
Plattformtechnologien (Antikörper, Checkpoint-Inhibition),
biopharmazeutische Produktion, Kombinations- und
Sequenztherapien; höchste Wachstumsrate aller Cluster
(Proteinkinasehemmer L01H +14,0 % p. a.).
Gefährdung durch das GKV-BStabG
• Ein onkologisches bereits preisverhandeltes Präparat kann gleichzeitig vom
(dynamischen) Herstellerabschlag, vom Rabattvertrag für patentgeschützte
Arzneimittel (PD-1/PD-L1- bzw. PARP-Inhibitoren als Pilotgruppen) und
Preis-Mengen-Vereinbarungen getroffen werden.
• Rabattverträge auf PD-1/PD-L1- und PARP-Inhibitoren zwingen
therapeutisch nicht beliebig austauschbare Wirkstoffe in einen
Preiswettbewerb.
• Die zusätzlichen Abschläge machen Markteinführungen neuer Indikationen
unkalkulierbar.
Quelle¿.IQVIA Q4/2025; GAmSi Bayern Q1/2025; Der Arzneimittelbrief 2026
https://der-arzneimittelbrief.com/artikel/2026/keytruda-teuerstes-krebsmedikament-moegliche-einsparpotenziale-und-wie-krankenkassen-unnoetig-finanziell-belastet-werden
Cluster Autoimmun- & entzündliche Erkrankungen
GKV-Umsatz 2025 ≈ 6,8 – 7,0 Mrd. € (L04C 2.404 Mio. € -24,1 %; L04B 2.242 Mio. € -4,1
%; N07A MS 1.681 Mio. €)
Versorgte Indikationen
Rheumatoide Arthritis, Psoriasis/Psoriasisarthritis, Morbus Crohn,
Colitis ulcerosa, atopische Dermatitis, Multiple Sklerose, Spondylitis
ankylosans
Leitpräparate
(Wirkstoffklassen)
Anti-TNF-Inhibitoren (Adalimumab), Interleukin-Inhibitoren
(Ustekinumab, Risankizumab, Secukinumab, Dupilumab), JAK-
Inhibitoren (Upadacitinib), MS-Mittel
Investitionsschwerpunkt
Biologika und niedermolekulare Immunmodulatoren (JAK),
Indikationserweiterungen über mehrere chronische Erkrankungen;
bereits intensiver Biosimilar-Wettbewerb (L04C -24,1 % Umsatz bei
nur -4,9 % Absatz, getrieben durch das Ustekinumab-Biosimilar).
Gefährdung durch das GKV-BStabG
• Das Cluster steht bereits unter starkem Biosimilar-Preiswettbewerb
(Umsatz L04C -24,1 % zzgl. hoher vertraulicher Rabatte). Der (dynamische)
Herstellerabschlag legt sich zusätzlich auf die verbleibenden
patentgeschützten Wirkstoffe – mit dem Risiko, dass einzelne Indikationen
unwirtschaftlich werden.
• JAK-Inhibitoren stehen auf der Pilotliste für Rabattverträge auf
patentgeschützte Arzneimittel. Sie werden damit doppelt erfasst: durch den
dynamischen Abschlag und durch einen Substitutionszwang nach
Rabattvertrag – trotz unterschiedlicher Sicherheitsprofile und Zulassungen.
Quelle¿.IQVIA Q4/2025 (L04C 2.404 Mio. €, L04B 2.242 Mio. €); GAmSi Bayern Q1/2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Cluster Diabetes & Stoffwechsel
GKV-Umsatz 2025 ≈ 5,0 – 5,2 Mrd. € (A10P SGLT2 2.013 Mio. € +15,1 %; A10S GLP-1
1.261 Mio. € +56,0 %; A10C Insulin 1.186 Mio. €)
Versorgte Indikationen Typ-2-Diabetes, Herzinsuffizienz (HFrEF/HFpEF), chronische
Niereninsuffizienz; kardiometabolische Folgeerkrankungen
Leitpräparate
(Wirkstoffklassen)
SGLT2-Hemmer (Empagliflozin, Dapagliflozin), GLP-1-Agonisten
(Semaglutid, Tirzepatid), Insulin-Analoga
Investitionsschwerpunkt
Indikationsausweitung kardiometabolischer Wirkstoffe (Herz, Niere);
stärkstes Mengen- und Umsatzwachstum im gesamten GKV-Markt
(GLP-1-Agonisten +56 % Umsatz, +24,2 % Absatz), hohe Public-
Health-Relevanz.
Gefährdung durch das GKV-BStabG
• Der (dynamische) Herstellerabschlag koppelt die Rabatthöhe an das
Ausgabenwachstum des Patentmarktes. Gerade die wachstumsstärksten
Cluster – SGLT2-Hemmer (+15,1 %) und GLP-1-Agonisten (+56 %) –
treiben damit ihren eigenen Zwangsrabatt nach oben und kumulieren so
die Belastung über die Jahre.
• Die Preis-Mengen-Regelung als gesetzliche Auffanglösung (ohne
Schiedsstellenbefassung) legt sich zusätzlich auf volumenstarke
Stoffwechseltherapien und erhöht die Belastung ein weiteres Mal.
Quelle¿.IQVIA Q4/2025 (A10P, A10S, A10C); GAmSi Bayern Q1/2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Cluster Herz-Kreislauf & Thrombose
GKV-Umsatz 2025 ≈ 2,9 – 3,0 Mrd. € (B01F Direkte Faktor-Xa-Hemmer 2.705 Mio. € +0,8
%); mit Lipidsenkern/PCSK9 ≈ 4,4 – 5,0 Mrd. €
Versorgte Indikationen
Schlaganfall-Prävention bei Vorhofflimmern, Therapie und Prophylaxe
von Venenthrombose und Lungenembolie, Herzinsuffizienz,
Sekundärprävention kardiovaskulärer Ereignisse
Leitpräparate
(Wirkstoffklassen)
Direkte Faktor-Xa-Hemmer (Apixaban, Rivaroxaban, Edoxaban), ARNI
(Sacubitril/Valsartan), PCSK9-Inhibitoren
Investitionsschwerpunkt
Großvolumige Versorgung mit hohem Public-Health-Nutzen
(Schlaganfall-Vermeidung); Lebenszyklus-Management und
Folgeindikationen.
Gefährdung durch das GKV-BStabG
• PCSK9-Inhibitoren sind eine der fünf Pilot-Wirkstoffgruppen für
Rabattverträge – ein Eingriff in die Sekundärprävention. Gleichzeitig greift
auf patentgeschützte Wirkstoffe des Clusters der (dynamische)
Herstellerabschlag; beide Maßnahmen wirken übereinander.
• Faktor-Xa-Hemmer (orale Antikoagulanzien, B01F: 2.705 Mio. € 2025)
zählen zu den umsatzstärksten Präparaten überhaupt und sind
lebensnotwendig für die Schlaganfall-Prävention. Diese pauschalen,
kumulierenden Abschläge gefährden die wirtschaftliche Versorgung
großer Patientengruppen.
Quelle¿.IQVIA Q4/2025 (B01F 2.704,5 Mio. €); GAmSi Bayern Q1/2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Die pharmarelevanten Maßnahmen des GKV-BStabG
(Dynamischer) Herstellerabschlag (§ 130a Abs. 1b SGB V-E)
Was
Der bestehende Herstellerabschlag von 7 % auf patentgeschützte
Arzneimittel wird um eine dynamische Komponente ergänzt, die an die
Ausgabenentwicklung im Patentmarkt gekoppelt ist. Alternativ ist auch ein
fixer Gesamtrabatt von 15,5% in der Diskussion
Zeitplan
Jan.–Jun. 2027: statisch +3,5 Prozentpunkte (= 10,5 %). Ab Juli 2027:
jährlich dynamisch berechneter Zusatzabschlag, Höhe abhängig von
Ausgaben- und Einnahmenentwicklung.
Finanzieller
Umfang
1,1 Mrd. € (2027) bis 5,5 Mrd. € (2030) – eine Verfünffachung; Simulationen
zeigen einen Gesamtabschlag von über 20 % bis 2030.
Ausnahmen
Festbetragsarzneimittel, Generika, Biosimilars, Impfstoffe, patentfreie
versorgungskritische Arzneimittel nach §52b Abs. 3c AMG, patentfreie
Kinderarzneimittel nach §35 Abs. 5a SGB V, vom Preismoratorium befreite
Arzneimittel, Reserveantibiotika, Wirkstoffe mit klinischen Studien und
Produktion in Deutschland.
Auswirkungen
• Ein (dynamischer, jährlich neu festgesetzter) Zwangsrabatt entzieht
Investitions- und Standortentscheidungen die Kalkulations- und
Planungsgrundlage.
• Jeder zusätzliche Euro Rabatterhöhung schadet der Volkswirtschaft um bis
zu 3,80 Euro.9
Quellen¿.Pharma.Deutschland.―.vfa‗Factsheet·.BMG‗Referentenentwurf¡10
9VCI, Pressemitteilung zum GKV-Sparpaket, April 2026. https://www.vci.de/presse/pressemitteilungen/gkv-sparpaket-der-
bundesregierung.jsp
10Pharma Deutschland: Risiken des GKV-BStabG für Arzneimittelversorgung und Innovation.
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-
innovation/
https://www.vci.de/presse/pressemitteilungen/gkv-sparpaket-der-bundesregierung.jsp
https://www.vci.de/presse/pressemitteilungen/gkv-sparpaket-der-bundesregierung.jsp
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
Rabattverträge für patentgeschützte Arzneimittel
(§ 130e SGB V-E, neu)
Was
Krankenkassen dürfen erstmals Rabattverträge für patentgeschützte
Arzneimittel mit therapeutisch vergleichbarer Wirkung abschließen
(Clusterausschreibungen). Vertragsärzte müssen rabattierte Arzneimittel
verordnen. Ausnahmen sind unter hohem bürokratischem Aufwand zu
begründen..
Pilotphase
Vorerst befristet bis 31.12.2030, zunächst fünf Wirkstoffgruppen: JAK-
Inhibitoren, CGRP-Antagonisten, PARP-Inhibitoren, PCSK9-Inhibitoren, PD-
1/PD-L1-Inhibitoren.
Bericht über die Auswirkungen durch den GKV SV an das BMG.
Cluster-
Betroffenheit
Direkter Eingriff in Onkologie (PD-1/PD-L1, PARP), Herz-Kreislauf (PCSK9),
Autoimmun (JAK) und Neurologie (CGRP).
Auswirkungen
• Innovative, oft nicht gleichwertige Wirkstoffe werden nach ihrer
Nutzenbewertung im AMNOG in einen reinen Preiswettbewerb gezwungen.
Das Ergebnis des AMNOG Verfahrens wird damit gänzlich entwertet. Das
RisikoDas Risiko für die Versorgung sind Marktrücknahmen und eine
eingeschränkte Therapiewahl für Patientinnen und Patienten. Die
Maßnahmen führen zu einer Verschlechterung der Versorgung für bestimmte
Therapiegebiete
• Rabattverträge waren bislang Generika vorbehalten. Ihre Ausweitung auf
den Patentmarkt unterläuft die bereits verhandelten AMNOG-
Erstattungsbeträge und addiert sich auf den dynamischen
Herstellerabschlag derselben Wirkstoffe.
Quellen¿.Pharma.Deutschland¿.Inhalte.des.GKV‗BStabG¡11
11Pharma Deutschland: Inhalte des GKV-Beitragssatzstabilisierungsgesetzes.
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
Preis-Mengen-Regelung
Was Die im Rahmen der 130b SGB V zu verhandelnde Preis-Mengen Regelung
wird gesetzlich festgeschrieben.
Finanzieller
Umfang
Je 100 Mio.€ Umsatz plus 1% Preisabschlag. Das ist eine Verzehnfachung
der bisherigen Preis-Mengen-Regel die im Rahmen des GKV-FinStabG in
2023 geschaffen wurde
Cluster-
Betroffenheit
Alle Arzneimittel mit Erstattungsbetrag nach §130b SGB V, Rückwirkung
durch Sonderkündigungsrecht
Auswirkungen
• Eine starrer Preis-Mengen-Algorithmus nimmt der Kassen und der Industrie
Verhandlungsfreiheit. Es kann nicht mehr der Einzelfall berücksichtigt
werden
• Mengen steigen durch mehr Nachfrage nach einem Arzneimittel. Gründe
dafür sind Demographie (mehr Arzneimittelverbrauch) oder der hohe Nutzen
für den Patient. Diese Regelung bestrafft also gerade Arzneimittel, die für
den Patienten einen hohen Wert bieten
Kumulative Wirkung der Maßnahmen
Herstellerabschlag, Rabattverträge für patentgeschützte Arzneimittel und die Preis-
Mengen greifen gleichzeitig und übereinander in die Innovationscluster Onkologie,
Autoimmun, Diabetes und Herz-Kreislauf ein. Diese kumulierenden Effekte werden
sich unmittelbar auf die Therapievielfalt, die Markteinführungen und die langfristige
Produktionsinvestitionen am Standort Deutschland auswirken und sich bei der
Arzneimittelversorgung, der Wirtschaftskraft der Pharmazeutischen Industrie und
damit der wirtschaftlichen Entwicklung Deutschlands negativ bemerkbar machen.
Die kombinierte Netto-Belastung der Pharmaindustrie aus dynamischem
Herstellerabschlag, Rabattverträgen und Preis-Mengen-Regelung beziffert das BMG
für 2030 auf 5,75 Mrd. Euro – knapp 19 % der Gesamteinsparungen über alle
Sektoren, obwohl der Arzneimittelmarkt nur 12% der Leistungsausgaben ausmacht.
Instrument Aktuell Geplant 2027
Allg. Herstellerabschlag 7 % 10,5 % (dynamisch)
Alternativ fixer
Herstellerabschlag 7% 15,5%
Rabattverträge Patent-AM nicht möglich
Pilot für 5 Wirkstoffgruppen,
Annahme 30% Rabatt
(Techniker Krankenkasse in
Pharma Dialog Äußerungen
von 50%)
Preis-Mengen-Vereinbarung 0,1% pro 100
Mio € 1% pro 100 Mio €
Mehrfachbelastung je Cluster
Die folgende Matrix macht sichtbar, dass die meisten Cluster nicht von einer, sondern
von mehreren Maßnahmen gleichzeitig getroffen werden. Genau diese Überlagerung –
nicht die einzelne Maßnahme – ist die eigentliche Gefahr für Innovation und Versorgung.
Cluster AMNOG
Prozess
(Dyn.)
Herstellerabschlag
Rabattvertrag
(Pilot)
Preis-
Mengen-
Regelung
Belastungsstufen
Onkologie &
Immuntherapien ja ja ja (PD-1/PD-
L1, PARP) ja 4-fach
Autoimmun &
Entzündung ja ja ja (JAK) ja 4-fach
Herz-Kreislauf &
Thrombose ja ja ja (PCSK9) ja 4-fach
Diabetes &
Stoffwechsel ja ja
(selbstverstärkend) – ja 3-fach
Lesehilfe¿.«Belastungsstufen».zählt?.wie.viele.der.kritisierten.Instrumente.einen.Cluster.direkt.erfassen¡.Das.Onkologie‗
Cluster.trägt.mit.vier.sich.überlagernden.Maßnahmen.die.höchste.kumulative.Belastung·.im.Diabetes‗Cluster.verstärkt.der.
dynamische.Abschlag.durch.die.Wachstumskopplung.sich.selbst¡12
12Eigene Darstellung auf Basis Pharma Deutschland: Inhalte des GKV-BStabG; § 130a/§ 130e SGB V-E.
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
Zwei exemplarische Beispiele wie sich die
Kumulation finanziell auswirken wird am Beispiel des
statischen Herstellerabschlages
Ein Onkologikum oder ein anderes patentgeschütztes Präparat kann 2027 ff. zusätzlich
zum bereits verhandelten AMNOG-Erstattungsbetrag und zum Preismoratorium zur
selben Zeit dem (dynamischen) Herstellerabschlag, einem Rabattvertrag (PD-1/PD-L1
oder PARP) und Preis-Mengenvereinbarungen unterliegen.
Jede Maßnahme aus dem GKV-Beitragssatz-Stabilisierungs-Gesetz mag für sich
begrenzt erscheinen. In der Überlagerung der Maßnahmen entsteht eine Belastung, die
einzelne Indikationen oder Wirkstoffe unwirtschaftlich machen und zu
Marktrücknahmen führen kann.
Instrument Präparat xy 100 Mio €
Umsatz
Präparat xy 500 Mio €
Umsatz
AMNOG Verfahren z.B.
Beträchtlicher Zusatznutzen -30%
verhandelter Erstattungsbetrag,
(Mittelwert AMNOG
Verhandlungen,
Herstellerabschlag abgelöst)
-30% bereits erfolgt -30% bereits erfolgt
Neu:
Allg. Herstellerabschlag -15,5% 15,5%
Rabattverträge Patent-AM
(geschätzt anhand von
Kassenerwartungen)
-30% -30%
Preis-Mengen-Vereinbarung 100 Mio € x 1% = -1% 500 Mio € x 1% = -5%
Ergebnis in Prozent (Summe
Maßnahmen BStabG) -46,5% - 50,5%
Ergebnis in € (Summe
Maßnahmen BStabG) 53,5 Mio € nach Rabatten 247,5 Mio € nach Rabatten
Diese Beispiele zeigen sehr eindrücklich was für extreme Auswirkungen die Kumulation
der Rabatte auf die Umsätze der Industrie hat. Dieses wird noch verschärft durch
internationale Preisreferenzierung, die die Auswirkungen auf den internationalen
Märkten für die Industrie ca. mit dem Faktor 4 erhöht.
Jedes Unternehmen muss sich die betriebswirtschaftliche Frage stellen, ob es
ökonomisch sinnvoll ist die Arzneimittel in Deutschland weiter zu vertreiben. Das ist
keine Drohung, sondern betriebswirtschaftliche Realität, wie in jeder anderen Branche
auch.
Einordnung und Methodik
• Pharma Deutschland hat die Wirkung des GKV-
Beitragssatzstabilisierungsgesetzes (GKV-BStabG) auf die forschende
Pharmaindustrie in Deutschland analysiert. Als Grundgesamtheit dienen die
umsatzstärksten patentgeschützten Präparate bzw. ihre Hersteller im
deutschen GKV-Markt. Die Darstellung der Auswirkungen erfolgt nach vier
Therapie-Clustern, um die gesellschaftliche Bedeutung der betroffenen
Versorgung in den Vordergrund zu stellen.
• Der GKV-Arzneimittelmarkt erreichte 2025 ein Volumen von rund 58,49 Mrd.
Euro (+5,9 % gegenüber 2024);13. Auf patentgeschützte Arzneimittel entfielen
davon rund 54 Prozent der Kosten. Genau dieser hochinnovative Patentmarkt
steht im Zentrum der geplanten Sparmaßnahmen.
• Alle quantitativen Aussagen sind über Fußnoten mit den jeweiligen Primär- bzw.
Verbandsquellen belegt. Die Marktwerte 2025 stammen aus dem IQVIA
Pharma-Marktbericht Q4/2025 (Gesamtjahr 2025, Bundesdaten) und dem BMG
(KV45). Cluster-Umsätze sind Schätzungen auf Basis der ATC-Gruppen des
IQVIA-Berichts 2025 und der GAmSi-Quartalsdaten (Bayern KV71 Q1/2025)
sowie der Hauptindikationen; Überschneidungen zwischen Clustern (z. B.
SGLT2-Hemmer in Diabetes und Herzinsuffizienz) sind möglich und im Text
gekennzeichnet.
Quellen und Hinweise:
• Die Datenbasis bilden der GKV-GAmSi-Quartalsbericht 2025, die IQVIA
Pharma-Marktberichte Q2–Q4/2025 mit Bundesdaten für das Gesamtjahr 2025,
der IGES Arzneimittel-Atlas 2025, der AOK Arzneimittel-Kompass 2025, das
arznei-telegramm 8/2025 sowie ergänzende Verbands- und
Ministeriumsquellen.
• Zentrale Primärquellen sind insbesondere IQVIA Pharma-Marktbericht Q2–
Q4/2025, BMG Finanzentwicklung GKV 2025 (KV45), GKV-GAmSi Bayern
KV71 Q1/2025, IGES Arzneimittel-Atlas 2025, AOK Arzneimittel-Kompass
2025, arznei-telegramm 8/2025, IW Köln PharmaKompakt 2025, vfa AMNOG-
Daten und der BMG-Referentenentwurf zum GKV-BStabG.
• Die Cluster-Umsätze sind Schätzungen auf Basis der ATC-Gruppen und der
Hauptindikationen; Überschneidungen zwischen Clustern, etwa bei SGLT2-
Hemmern in Diabetes und Herzinsuffizienz, sind möglich und im Text
gekennzeichnet.
• Vollständige URLs finden sich in den Fußnoten.
Abkürzungs- und Begriffsverzeichnis
Gesetze und Paragrafen
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
AMNOG Arzneimittelmarkt-
Neuordnungsgesetz
Seit 2011 geltendes Gesetz. Regelt, dass für
jedes neue Arzneimittel der Zusatznutzen
bewertet und daraufhin ein Erstattungspreis
mit den Kassen verhandelt wird.
GKV-BStabG GKV-
Beitragssatzstabilisierungsgesetz
Das im Fact-Sheet analysierte „Spargesetz
2025/26“. Soll die Beitragssätze der
gesetzlichen Krankenversicherung
stabilisieren – u. a. durch neue Abschläge auf
patentgeschützte Arzneimittel.
SGB V Fünftes Buch Sozialgesetzbuch Das zentrale Gesetzbuch zur gesetzlichen
Krankenversicherung in Deutschland.
SGB V-E Sozialgesetzbuch V –
Entwurfsfassung
Der Zusatz „-E“ kennzeichnet eine geplante,
noch nicht in Kraft getretene Fassung
(Gesetzentwurf).
§ 130a SGB V Paragraf zum Herstellerabschlag
Rechtsgrundlage für den (auch dynamischen)
Zwangsrabatt, den Hersteller den Kassen
gewähren müssen.
§ 130b SGB V Paragraf zur
Erstattungsbetragsverhandlung
Regelt die AMNOG-Preisverhandlung; Abs. 3
enthielt die sogenannten „Leitplanken“.
§ 130e SGB V Paragraf zu Kombinations- und
Patent-Rabatten
Rechtsgrundlage für den
Kombinationsabschlag und – neu geplant – für
Rabattverträge auf patentgeschützte
Arzneimittel.
BVerfG Bundesverfassungsgericht Höchstes deutsches Gericht; prüfte 2025 die
Verhältnismäßigkeit des Preismoratoriums.
G-BA Gemeinsamer Bundesausschuss
Oberstes Beschlussgremium der
Selbstverwaltung im Gesundheitswesen;
benennt u. a. die von Abschlägen betroffenen
Wirkstoff-Kombinationen.
Institutionen, Verbände und Datenquellen
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
AOK Allgemeine Ortskrankenkasse Größte gesetzliche Krankenkassengruppe;
gibt den „Arzneimittel-Kompass“ heraus.
arznei-telegramm Unabhängiger Arzneimittel-
Informationsdienst
Herstellerunabhängige Fachpublikation zur
Bewertung von Arzneimitteln.
BMG Bundesministerium für Gesundheit Zuständiges Ministerium; veröffentlicht u. a.
die GKV-Finanzentwicklung (Statistik „KV45“).
BPI Bundesverband der
Pharmazeutischen Industrie
Branchenverband der Pharmaindustrie in
Deutschland.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
CDMO Contract Development and
Manufacturing Organization
Auftragsentwickler und -hersteller;
Dienstleister, die Arzneimittel für andere
Firmen produzieren.
GAmSi GKV-Arzneimittel-
Schnellinformation
Amtliche, zeitnahe Statistik über
Arzneimittelverordnungen zu Lasten der
gesetzlichen Krankenkassen.
GKV Gesetzliche Krankenversicherung
Das solidarisch finanzierte
Pflichtversicherungssystem, in dem rund 90 %
der Bevölkerung versichert sind.
GKV-Spitzenverband Spitzenverband Bund der
Krankenkassen
Zentrale Interessenvertretung aller
gesetzlichen Kranken- und Pflegekassen;
verhandelt u. a. die Erstattungsbeträge.
IGES IGES Institut
Forschungs- und Beratungsinstitut im
Gesundheitswesen; erstellt den „Arzneimittel-
Atlas“.
IQVIA IQVIA
(Marktforschungsunternehmen)
Führender Anbieter von Markt- und
Verordnungsdaten im Gesundheitswesen;
Quelle des „Pharma-Marktberichts“.
IW Köln Institut der deutschen Wirtschaft
Köln
Wirtschaftsforschungsinstitut; erstellt u. a. die
Studie „PharmaKompakt“.
KV45 / KV71 Amtliche GKV-Finanz- bzw.
Statistikvordrucke
Standardisierte Meldeformulare der Kassen;
„KV45“ = GKV-Finanzergebnisse, „KV71“ =
regionale Verordnungsstatistik (hier Bayern).
MWV Medizinisch Wissenschaftliche
Verlagsgesellschaft
Verlag, in dem u. a. der Arzneimittel-Atlas
erscheint.
VCI Verband der Chemischen Industrie Branchenverband der Chemie- und
Pharmaindustrie in Deutschland.
vfa Verband forschender
Arzneimittelhersteller
Interessenverband der forschenden
Pharmaunternehmen in Deutschland.
Sparmaßnahmen und Begriffe der Preisregulierung
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
AMNOG-Leitplanken Preisobergrenzen im AMNOG-
Verfahren
Gesetzliche Deckelung des verhandelbaren
Preises je nach Zusatznutzen. Werden durch
das GKV-BStabG abgeschafft (Erfolg aus
Branchensicht).
Dynamischer
Herstellerabschlag
An das Ausgabenwachstum
gekoppelter Zwangsrabatt
Pflichtrabatt der Hersteller auf
patentgeschützte Arzneimittel, der mit
steigenden Patentmarkt-Ausgaben
automatisch mitwächst – Kern der Kritik im
Fact-Sheet.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
Erstattungsbetrag Verhandelter Preis in der GKV
Der zwischen Hersteller und Kassen
ausgehandelte Preis, den die GKV für ein
neues Arzneimittel erstattet.
Festbetrag Erstattungshöchstgrenze für
Arzneimittelgruppen
Fester Höchstbetrag, den die Kasse für
vergleichbare Wirkstoffe zahlt; darüber zahlt
der Patient die Differenz.
Herstellerabschlag Gesetzlicher Pflichtrabatt der
Hersteller
Fester (bislang 7 %) Zwangsrabatt auf den
Herstellerabgabepreis patentgeschützter
Arzneimittel.
Kombinationsabschlag Rabatt auf Kombinationstherapien
(§ 130e)
Seit Oktober 2024 20 % Abschlag auf
patentgeschützte Arzneimittel, die in vom G-
BA benannten Kombinationen eingesetzt
werden.
Nutzenbewertung Bewertung des Zusatznutzens
(AMNOG)
Prüfung, ob ein neues Arzneimittel gegenüber
der bisherigen Standardtherapie einen
belegten Zusatznutzen bietet.
Preismoratorium Einfrieren der Herstellerpreise
Seit 2010 sind die Herstellerpreise auf dem
Stand von August 2009 eingefroren;
Verlängerung bis 2030 geplant.
Preis-Mengen-
Regelung
Automatische Preissenkung bei
hohen Absatzmengen
Mechanismus, der bei stark steigenden
Verordnungsmengen den Preis senkt – als
gesetzliche Auffanglösung vorgesehen.
Rabattverträge Exklusive Preisvereinbarungen
einzelner Kassen
Bisher nur bei Generika üblich; sollen künftig
(Pilot) auch für patentgeschützte Arzneimittel
gelten, mit Substitutionspflicht für Ärzte.
Substitution Austausch durch ein anderes
Präparat
Ersetzen des verordneten Arzneimittels durch
ein rabattiertes, therapeutisch vergleichbares
Präparat.
Tagesdosen (DDD) Definierte Tagesdosis (Defined
Daily Dose)
Statistische Maßeinheit für die verordnete
Arzneimittelmenge – erlaubt
Mengenvergleiche unabhängig vom Preis.
Zwangsrabatt Gesetzlich vorgeschriebener
Pflichtrabatt
Umgangssprachlich für gesetzlich verordnete
Abschläge (z. B. Herstellerabschlag), die
Hersteller ohne Verhandlung gewähren
müssen.
ATC-Codes der Wirkstoffgruppen
Das ATC-System (Anatomisch-Therapeutisch-Chemische Klassifikation) ist das
amtliche, weltweit einheitliche Ordnungsschema der WHO für Arzneimittelwirkstoffe.
Jeder Code steht für eine bestimmte Wirkstoffgruppe. Im Fact-Sheet dienen die Codes
dazu, Umsätze markenneutral einzelnen Cluster-Bereichen zuzuordnen.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
A10C Insuline und Insulin-Analoga Blutzuckersenkende Hormonpräparate zur
Diabetes-Behandlung.
A10P SGLT2-Hemmer
Moderne orale Diabetes-Medikamente, die
Zucker über den Urin ausscheiden; auch bei
Herz- und Nierenschwäche wirksam.
A10S GLP-1-Rezeptor-Agonisten
Injizierbare Diabetes- und Adipositas-
Wirkstoffe; wachstumsstärkste Gruppe im
Markt (z. B. Semaglutid).
B01 Antithrombotische Mittel Übergeordnete Gruppe der
Blutgerinnungshemmer.
B01F Direkte Faktor-Xa-Hemmer
Moderne orale Gerinnungshemmer zur
Schlaganfall- und Thrombosevorbeugung (z.
B. Apixaban, Rivaroxaban).
L01G Monoklonale Antikörper
(Antineoplastika) Gezielt wirkende Krebs-Antikörpertherapien.
L01H Proteinkinasehemmer
Zielgerichtete Krebsmedikamente, die
tumorfördernde Enzyme blockieren;
wachstumsstärkste Onkologie-Gruppe.
L02B Hormonantagonisten
Krebstherapien, die hormonabhängiges
Tumorwachstum bremsen (z. B. bei Prostata-
oder Brustkrebs).
L04B / L04C Immunsuppressiva /
Immunmodulatoren
Wirkstoffe gegen überschießende Immun- und
Entzündungsreaktionen (z. B. bei Rheuma,
Psoriasis).
N07A Mittel gegen Erkrankungen des
Nervensystems
Im Fact-Sheet konkret die Wirkstoffe gegen
Multiple Sklerose (MS).
Wirkstoffklassen und medizinische Fachbegriffe
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
Anti-TNF TNF-alpha-Inhibitoren
Biologika, die den Entzündungsbotenstoff
TNF-alpha blockieren (z. B. bei Rheuma,
Morbus Crohn).
ARNI Angiotensin-Rezeptor-Neprilysin-
Inhibitor
Kombinationswirkstoff zur Behandlung der
Herzschwäche (Sacubitril/Valsartan).
Biologika Biotechnologisch hergestellte
Arzneimittel
Aus lebenden Zellen gewonnene, komplexe
Wirkstoffe (z. B. Antikörper) – häufig bei Krebs
und Autoimmunerkrankungen.
BTK-Inhibitoren Bruton-Tyrosinkinase-Inhibitoren Zielgerichtete Wirkstoffe gegen bestimmte
Blutkrebsarten.
CD38-Antikörper Antikörper gegen das
Oberflächenmerkmal CD38
Krebstherapie, v. a. beim multiplen Myelom
(Knochenmarkkrebs).
CDK-Inhibitoren Cyclin-abhängige-Kinase-
Inhibitoren
Zielgerichtete Wirkstoffe, u. a. beim
Brustkrebs.
CGRP-Antagonisten Calcitonin-Gene-Related-Peptide-
Antagonisten
Moderne Migräne-Wirkstoffe; eine der fünf
Pilotgruppen für Rabattverträge.
Checkpoint-Inhibition Immun-Checkpoint-Hemmung Krebs-Immuntherapie, die die körpereigene
Immunabwehr gegen Tumorzellen „entfesselt“.
EGFR-Inhibitoren Epidermal-Growth-Factor-
Receptor-Inhibitoren
Zielgerichtete Krebstherapie, u. a. bei
Lungenkrebs.
Faktor-Xa-Hemmer Direkte orale Antikoagulanzien Blutgerinnungshemmer zur Schlaganfall- und
Thrombosevorbeugung (siehe ATC B01F).
GLP-1-Agonisten GLP-1-Rezeptor-Agonisten Diabetes- und Adipositas-Wirkstoffe (z. B.
Semaglutid, Tirzepatid); siehe ATC A10S.
HFrEF / HFpEF Herzinsuffizienz mit reduzierter /
erhaltener Pumpfunktion
Zwei medizinische Formen der
Herzschwäche.
Interleukin-Inhibitoren Hemmstoffe von Interleukinen
Biologika, die entzündungsfördernde
Botenstoffe (Interleukine) blockieren (z. B. bei
Psoriasis).
JAK-Inhibitoren Januskinase-Inhibitoren
Niedermolekulare (Tabletten-)Wirkstoffe gegen
Autoimmunerkrankungen; eine der fünf
Rabattvertrags-Pilotgruppen.
MAB Monoklonale Antikörper
Im Labor hergestellte, hochspezifische
Antikörper (Wortendung „-mab“, z. B. bei
Krebs).
MS Multiple Sklerose Chronisch-entzündliche Erkrankung des
zentralen Nervensystems.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
PARP-Inhibitoren Poly-ADP-Ribose-Polymerase-
Inhibitoren
Zielgerichtete Krebstherapie (u. a. Eierstock-,
Brustkrebs); eine der fünf Rabattvertrags-
Pilotgruppen.
PCSK9-Inhibitoren PCSK9-Hemmer
Cholesterinsenker zur Vorbeugung von Herz-
Kreislauf-Ereignissen; eine der fünf
Rabattvertrags-Pilotgruppen.
PD-1 / PD-L1-
Inhibitoren
Programmed-Cell-Death-(Ligand)-
Inhibitoren
Zentrale Krebs-Immuntherapien (Checkpoint-
Inhibitoren); eine der fünf Rabattvertrags-
Pilotgruppen.
Proteinkinasehemmer Kinase-Inhibitoren
Zielgerichtete Krebsmedikamente, die
tumorfördernde Enzyme blockieren (siehe
ATC L01H).
SGLT2-Hemmer Natrium-Glucose-Cotransporter-2-
Hemmer
Diabetes-Wirkstoffe mit Zusatznutzen bei
Herz- und Nierenschwäche (siehe ATC A10P).
Einheiten und sonstige Abkürzungen
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
DDD Defined Daily Dose (definierte
Tagesdosis)
Statistische Vergleichseinheit für verordnete
Arzneimittelmengen.
F&E Forschung und Entwicklung Ausgaben für die Erforschung und
Entwicklung neuer Arzneimittel.
Mrd. € Milliarden Euro
Mio. € Millionen Euro
p. a. per annum (pro Jahr)
Q1–Q4 Quartale 1 bis 4 eines Jahres
Verteilung des GKV-Umsatzes nach Erkrankungsschwere (2025)
Das GKV-BStabG belastet ausgerechnet den Marktteil am stärksten, der die Versorgung Schwerstkranker sichert und die forschungs- und investitionsstärkste Industrie Deutschlands trägt.6F
Die vier Therapie-Cluster (Datenbasis 2025)
Übersicht: Cluster-Umsätze im GKV-Markt 2025
Cluster Onkologie & Immuntherapien
Cluster Autoimmun- & entzündliche Erkrankungen
Cluster Diabetes & Stoffwechsel
Cluster Herz-Kreislauf & Thrombose
Die pharmarelevanten Maßnahmen des GKV-BStabG
(Dynamischer) Herstellerabschlag (§ 130a Abs. 1b SGB V-E)
Rabattverträge für patentgeschützte Arzneimittel
(§ 130e SGB V-E, neu)
Preis-Mengen-Regelung
Kumulative Wirkung der Maßnahmen
Herstellerabschlag, Rabattverträge für patentgeschützte Arzneimittel und die Preis-Mengen greifen gleichzeitig und übereinander in die Innovationscluster Onkologie, Autoimmun, Diabetes und Herz-Kreislauf ein. Diese kumulierenden Effekte werden sich un...
Mehrfachbelastung je Cluster
Zwei exemplarische Beispiele wie sich die Kumulation finanziell auswirken wird am Beispiel des statischen Herstellerabschlages
Einordnung und Methodik
Gesetze und Paragrafen
Institutionen, Verbände und Datenquellen
Sparmaßnahmen und Begriffe der Preisregulierung
ATC-Codes der Wirkstoffgruppen
Wirkstoffklassen und medizinische Fachbegriffe
Einheiten und sonstige Abkürzungen
03.07.2026
Datei
11059/26 1
LIFE.5 EN
Council of the
European Union
Brussels, 30 June 2026
(OR. en)
11059/26
SAN 517
PHARM 117
MI 699
MAP 143
POLCOM 237
IND 447
COMPET 836
CODEC 1303
Interinstitutional File:
2025/0102 (COD)
OUTCOME OF PROCEEDINGS
From: General Secretariat of the Council
To: Delegations
No. prev. doc.: 10713/26
Subject: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL laying a framework for strengthening the availability
and security of supply of critical medicinal products as well as the
availability of, and accessibility of, medicinal products of common interest,
and amending Regulation (EU) 2024/795
- Letter to the Chair of the European Parliament Committee on Public
Health
Following the Permanent Representatives Committee meeting of 30 June 2026 which endorsed the
final compromise text with a view to agreement, delegations are informed that
the Presidency sent the attached letter, together with its Annex, to the Chair of the European
Parliament Committee on Public Health.
11059/26 2
ANNEX LIFE.5 EN
ANNEX
11059/26 3
ANNEX LIFE.5 EN
PE-CONS No/YY - 2025/102(COD)
REGULATION (EU) 2026/…
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of …
establishing a framework to strengthen the security of supply and the availability of critical
medicinal products, as well as the availability ▌ and accessibility of ▌ medicinal products of
common interest, and amending Regulation (EU) 2024/795
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114
thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee1,
Acting in accordance with the ordinary legislative procedure2,
1 OJ C ▌, C/2025/4214, 20.8.2025, ELI: http://data.europa.eu/eli/C/2025/4214/oj.
2 Position of the European Parliament of … [(OJ …)/(not yet published in the Official
Journal)] and position of the Council at first reading of … [(OJ …)/(not yet published in
the Official Journal)]. Position of the European Parliament of … [(OJ …)/(not yet
published in the Official Journal)] [and decision of the Council of …].
http://data.europa.eu/eli/C/2025/4214/oj
11059/26 4
ANNEX LIFE.5 EN
Whereas:
(1) Availability of critical medicinal products is essential for the Union and the functioning
of the internal market. Pursuant to Article 9 of the Treaty on the Functioning of the
European Union (‘TFEU’) and Article 35 of the Charter of fundamental Rights of the
European Union ▌, the Union is to ensure a high level of human health protection in all
Union policies and activities. The availability of safe, efficacious and high-quality
medicinal products, underpinned by resilient, secure and reliable supply chains forming
the backbone of the supply of medicinal products, is vital for achieving this objective and
▌safeguarding public health across the Union while contributing to the Union’s overall
security. To safeguard the functioning of the internal market it is therefore necessary to
create a common Union framework to collectively address the challenges by
strengthening the security of supply and the availability of critical medicinal products.
(2) In recent years, the Union has experienced an increasing number of shortages of medicinal
products, including shortages of medicinal products for which insufficient supply affects
the continuity of care and the operational capacity of health systems and results in
serious harm or risk of serious harm to patients. In addition, the shortages of older
antibiotics, whose unavailability results in the necessity to substitute them, can
contribute to the increase of antimicrobial resistance. A stable and resilient supply of
critical medicines is therefore critical to the health of patients in the Union and the
proper functioning of health systems.
11059/26 5
ANNEX LIFE.5 EN
(3) Shortages of medicinal products can have very different and complex root causes, with
challenges identified along the entire pharmaceutical value chain which differ depending
on the specific characteristics of the supply chains of medicinal products. In particular,
shortages of medicinal products can result from supply chain disruptions and
vulnerabilities affecting the supply of active substances and key inputs, including starting
and raw materials. These include existing dependencies on a limited number of suppliers
globally and lack of Union capacities to produce certain medicinal products, their active
substances or key inputs. Through diversification of supply sources and investment in
local production, the Union can reduce its risk of exposure to shortages of medicinal
products. In cases of blood-derived and plasma-derived medicinal products, the
vulnerabilities can also result from limited collection capacity and unavailability of
donors.
(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union
have contributed to increased dependency on third country suppliers, in particular, for key
starting materials and active substances. Developing manufacturing capacity throughout
the supply chain requires substantial long-term investment in adequate industrial
infrastructure, strong research capabilities, regulatory predictability and a skilled
workforce. Setting up new manufacturing capacities in the Union for critical medicinal
products, their key inputs and active substances, and expanding or modernising existing
manufacturing capacities ▌ for those critical medicinal products, their key inputs and
active substances, which have often been on the market for a long time and are considered
to be relatively inexpensive, is currently not seen as a sufficiently attractive option for
private investment, also in view of lower energy costs, and less environmental and other
legal requirements elsewhere in the world. Workforce shortages and the need for
specialised skills in pharmaceutical manufacturing further add to the industrial challenges
to manufacturing in the Union. Targeted financial incentives, simplified administrative
processes, and better Union-level coordination can contribute to supporting efforts to
increase manufacturing capacities in the Union and strengthen the supply chains for critical
medicinal products.
11059/26 6
ANNEX LIFE.5 EN
(4a) While medicinal products shortages can occur for any type of medicinal product, they
often affect older, off-patent, and generic medicinal products, partly due to their low
profit margins, which reduce incentives for investment in robust manufacturing
capacity. Older, off-patent, and generic medicinal products make up the majority of the
medicinal products placed on the Union list of critical medicinal products established by
Regulation (EU) .../...3+. Many off-patent and generic medicinal products suppliers have
outsourced manufacturing or relocated production of finished medicinal products
outside the Union, and frequently source their active substances from third countries.
Consequently, the Union relies on a limited number of active substance suppliers and
manufacturers, many located outside its borders.
(5) To enhance the security of supply for medicinal products and thereby contribute to a high
level of public health protection, the Union has implemented a range of measures that
contribute to building a European Health Union. In particular, Regulation (EU) 2022/123
of the European Parliament and of the Council4 has reinforced the European Medicines
Agency’s (‘the Agency’) mandate by enhancing monitoring, coordination, and reporting
mechanisms to prevent and mitigate supply disruptions of critical medicinal products
across Member States. That Regulation also established the Agency’s Executive Steering
Group on Shortages and Safety of Medicinal Products (‘the MSSG’), which brings
together representatives from the Agency and Member States, to coordinate urgent actions
within the Union to manage existing shortages and issues related to the quality, safety ▌
and efficacy of medicinal products.
3 Regulation (EU) …/… of the European Parliament and of the Council of … laying
down Union procedures for the authorisation and supervision of medicinal products for
human use and establishing rules governing the European Medicines Agency, amending
Regulations (EC) No 1394/2007 and (EU) No 536/2014 and repealing Regulations (EC)
No 141/2000, (EC) No 726/2004 and (EC) No 1901/2006.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
4 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January
2022 on a reinforced role for the European Medicines Agency in crisis preparedness and
management for medicinal products and medical devices (OJ L 20, 31.2.2022, p. 1, ELI:
http://data.europa.eu/eli/reg/2022/123/oj).
http://data.europa.eu/eli/reg/2022/123/oj
11059/26 7
ANNEX LIFE.5 EN
(6) In addition, Regulation (EU) …/… +further strengthens the continuity of supply and
availability of medicinal products, inter alia by developing the core tasks already granted
to the Agency by Regulation (EU) 2022/123 and setting out a framework for the activities
to be deployed by the Member States and the Agency to improve the Union capacity to
react efficiently and in coordinated manner to support the shortages management and
security of supply of medicinal products, including by strengthening the obligations of
marketing authorisation holders with regard to shortages prevention and shortages
reporting or by establishing a Voluntary Solidarity Mechanism for medicinal products
that allows a Member State affected by a critical shortage of a medicinal product to
request supplies from other Member States.
(7) However, despite regulatory obligations on marketing authorisation holders to ensure the
continuous supply of medicinal products to meet patients’ needs and the additional
regulatory mechanism introduced by Regulations (EU) 2022/123 and (EU) …/… + to
mitigate and respond to shortages, the functioning of the market dynamics alone does not
always guarantee the availability of medicinal products. This risk is particularly evident in
cases of supply chain disruptions, especially when the supply of a given medicinal product
relies on a limited number of global suppliers and production facilities or where there is a
high dependency on a single or a limited number of third countries.
(8) As the Union market for medicinal products remains fragmented, there is a need for better
coordination between Member States to leverage in full the Union’s potential to strengthen
the security of supply of critical medicinal products and facilitate accessibility to other
products, without calling into question Member States’ responsibilities for the organisation
and delivery of health services and medical care. Uncoordinated national measures risk
disrupting the internal market, fail to address broader supply chain issues, and are
insufficient to resolve cross-border issues, including the Union's dependency on third
countries. The regulatory framework for medicinal products therefore needs to be
complemented by targeted actions providing for further harmonisation.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
11059/26 8
ANNEX LIFE.5 EN
(9) Some medicinal products of common interest which are key for the provision of adapted
care to patients, while not affected by supply security issues, might still not be available
and accessible to patients in some Member States, which results in inequalities in access
between patients in the Union. This might concern medicinal products for rare diseases,
antimicrobials, and other innovative, high-cost, or specialised treatments across various
therapeutic areas, such as oncology. Lack of access might be caused by a variety of
factors, including product or geographical demand market size, which can impact the
timely accessibility and availability of medicinal products in certain Member States. This
Regulation contributes to reducing inequalities among Member States, and to more
equitable access to medicinal products across the Union, so that patients enjoy the same
level of access regardless of their country of residence.
(9a) Because orphan medicinal products target rare and ultra-rare diseases and limited
patient’ populations, they would benefit from collaborative procurement that allows for
the aggregation of the demand of participating Member States. For this reason, those
medicinal products should qualify for such procurement procedures even where they are
not considered as medicinal products of common interest. To encourage early access
and availability in the Union of those medicinal products, certain advantages in the
permit-granting process should be also granted to their developers and manufacturers.
11059/26 9
ANNEX LIFE.5 EN
(10) The smooth functioning of the internal market and a high level of protection of human
health should be ensured as regards medicinal products. This Regulation should aim to
complement other Union pharmaceutical legislation by providing for a harmonised
framework supporting Member States’ coordinated efforts to encourage investments in
new, modernised and existing manufacturing capacities for critical medicinal products, by
encouraging the strategic use of public procurement instruments by the Member States as
well as the coordination of the Member States’ approaches, including through leveraging
aggregated demand through Commission facilitated collaborative procurement procedures
of critical medicinal products and medicinal products of common interest, as well as by
providing a framework to increase coordination between Member States in relation to
contingency stock requirements. Due to the international dimension of the security of
supply, in particular taking into account that diversification of supply chains and an overall
increase of supply are elements of a solution for ensuring the security of supply,
international cooperation should be encouraged.
(11) The measures introduced by this Regulation are without prejudice to marketing
authorisation holders’ obligations, in particular under Directive (EU) …/… of the
European Parliament and of the Council 5+, Regulation (EU) …/… ++ and Regulation (EU)
2022/123, including the obligation to ensure sufficient supplies of medicinal products,
within the limits of their responsibility. These measures are aligned with the principles of
the internal market. This Regulation is without prejudice to Union competition law,
including antitrust, merger and State aid rules.
5 Directive (EU) 2026/… of the European Parliament and of the Council of … on the
Union code relating to medicinal products for human use, and repealing Directives
2001/83/EC and 2009/35/EC.
+ OJ: please insert in the text the number of the Directive in document ST 7106/26
(2023/0132(COD)).
++ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
11059/26 10
ANNEX LIFE.5 EN
(11a) Data made available to competent authorities in accordance with Regulation (EU)
2025/327 of the European Parliament and of the Council6 on the European Health Data
Space (EHDS) can contribute to the implementation of this Regulation.
(12) While the primary objective of this Regulation should be to improve the functioning of the
internal market by establishing a framework to strengthen the security of supply and ▌
the availability of critical medicinal products, as well as the availability and accessibility
of medicinal products of common interest, given that a lack of critical medicinal products
can affect the functioning of the economy as a whole, this Regulation should also support
the Union’s competitiveness by fostering a more stable and predictable market
environment, reducing administrative barriers, encouraging investment and supporting
innovation in the pharmaceutical sector. Ensuring the security of supply and availability of
critical medicinal products and the availability and accessibility of ▌ medicinal products of
common interest should moreover contribute to the Union’s preparedness, resilience, and
economic and overall security, including when cross-border supply chains risk being
disrupted, therefore supporting the Union’s strategic autonomy.
(13) Taking into account the different root causes of the availability issues affecting critical
medicinal products and medicinal products of common interest, some measures should
apply to critical medicinal products only.
6 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11
February 2025 on the European Health Data Space and amending Directive
2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI:
http://data.europa.eu/eli/reg/2025/327/oj).
http://data.europa.eu/eli/reg/2025/327/oj
11059/26 11
ANNEX LIFE.5 EN
(14) Ensuring the security of supply and the availability of critical medicinal products for
patients in the Union to safeguard public health, patients’ safety and the economic and
overall security of the Union is a strategic objective of the Union. To achieve this, it is
important that the Member States and the Commission work together to strengthen the
security of supply and continuous availability of critical medicinal products in the Union
through measures that take full advantage of the potential of the internal market. In this
effort, the Commission has an important role to support the coordinated efforts of the
Members States.
(15) A well-defined list of critical medicinal products is essential to ensure that the measures
are targeted, effective ▌ and proportionate. The ▌ medicinal products covered by this
Regulation are those for which insufficient supply results in serious harm or risk of serious
harm to patients. For this reason this Regulation should apply to critical medicinal products
on the Union list of critical medicinal products, as established by Regulation (EU) …/… +.
That list builds upon the experiences of the ▌ Agency and Member States’ agencies that in
2024 ▌ identified a list of 276 critical medicinal products.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
11059/26 12
ANNEX LIFE.5 EN
(16) To ensure that the measures are applied where justified and proportionate, it is necessary to
demonstrate that some measures address a vulnerability in the supply chains of critical
medicinal products while taking into account the distinctive characteristics of each
category of critical medicinal products' supply chain. This Regulation should rely on the
vulnerability evaluation performed for the purpose of the application of the general
pharmaceutical legislation pursuant to Regulation (EU) No …/… +. To detect a
vulnerability in the supply chains it is necessary to look at aggregated data across all
medicinal products authorised in the Union and containing the same active substance, route
of administration and formulation. Such an approach allows for the determination whether,
for a critical medicinal product with a given active substance, the Union is highly
dependent on a single or a limited number of third countries, or a limited number of sites,
for active substances, key inputs, or finished dosage forms.
(17) Certain projects can have a positive impact on security of supply as they increase the
Union’s manufacturing capacity for critical medicinal products and strengthen the
resilience of the Union’s supply chains. In order to encourage private investments in these
projects, the concept of strategic projects should be introduced. Given their role in ensuring
the Union’s security of supply for critical medicinal products and contribution to the
objectives of preserving public health and protection of patients’ interests, the relevant
permit-granting authority should consider strategic projects to be in the public interest. To
ensure their expedient implementation, national authorities should be provided with
adequate resources to ensure that the relevant permit-granting processes are carried out
without delay, making available, in particular, any form of accelerated procedures that
exists in applicable Union and national law, whilst upholding the highest social, health
and environmental standards. National authorities should consider, when possible, their
streamlining as well as enable digital submission of required information.
11059/26 13
ANNEX LIFE.5 EN
(18) The designated authority should assess whether a given project is a strategic project. To
offer real advantage to strategic projects as regards shortened permitting timelines, such
assessments should be provided swiftly, without undue delay. When justified by the
complexity of the project being the subject of an assessment, the timeline for an
assessment can take up to 20 days. In order to accelerate and facilitate their deployment,
strategic projects should benefit from streamlined administrative processes, priority status
in the context of permit-granting procedures and related dispute resolution procedures,
where such processes, status and procedures already exist in national law, as well as ▌
be offered targeted ▌ support. It is necessary that the strategic project relies on
continuous supply of energy and gas to be able to produce the critical medicinal
products. For this reason the Member States could consider the strategic projects as
‘protected customer’ in accordance with Regulation 2017/1938 of the European
Parliament and of the Council 7 concerning measures to safeguard the security of gas
supply. The Member States should also give particular attention to small and medium-
sized enterprises (SMEs) which should have a fair chance to initiate strategic projects. This
Regulation should be applied in a manner that guarantees fair and equal competition
among all market players, regardless of their size and ownership structure. In order to
ensure uniform conditions for the implementation of this Regulation in the Member
States, a standard template for a request for recognition of a strategic project should be
provided for by means of implementing acts. Implementing powers should be conferred
on the Commission. Those powers should be exercised in accordance with Regulation
(EU) No 182/2011 of the European Parliament and of the Council8.
7 Regulation (EU) 2017/1938 of the European Parliament and of the Council of 25
October 2017 concerning measures to safeguard the security of gas supply and repealing
Regulation (EU) No 994/2010 (OJ L 280, 28.10.2017, p. 1, ELI:
http://data.europa.eu/eli/reg/2017/1938/oj).
8 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16
February 2011 laying down the rules and general principles concerning mechanisms for
control by the Member States of the Commission's exercise of implementing powers
(OJ L 55, 28.2.2011, p. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj).
http://data.europa.eu/eli/reg/2017/1938/oj
http://data.europa.eu/eli/reg/2011/182/oj
11059/26 14
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(18a) A project promoter should be able to request that their application for a permit is
granted the status of the highest national significance, if such a status exists in national
law, and be treated accordingly. National authorities are to grant the status of the
highest national significance to an application for a permit without prejudice to
obligations provided for in Union law.
(18b) A project promoter should be able to request that any dispute resolution procedure,
litigation, appeal and proceedings on judicial remedies related to the permit-granting
process, and the issuance of permits for a strategic project in the Union, is treated as
urgent if and to the extent to which national law provides for such an urgency
procedure.
(19) The production of medicinal products has environmental implications and might
negatively impact not only the environment itself but also human health. The
environmental assessments and authorisations required under Union law are an integral
part of the permit-granting process for strategic projects and an essential safeguard to
ensure that negative environmental impacts, including of a transboundary nature, are
prevented or minimised. However, to ensure that permit-granting processes for strategic
projects are predictable and timely, it should be possible to streamline the required
assessments and authorisations by the relevant authority, while not lowering the level of
environmental protection nor neglecting steps necessary for a proper assessment of
transboundary impacts in accordance with applicable law.
(19a) Acknowledging the importance of international cooperation in environmental matters,
this Regulation respects the obligations arising from the United Nations Economic
Commission for Europe (UNECE) Conventions. In particular, it is without prejudice to
the UNECE Convention on Access to Information, Public Participation in Decision-
making and Access to Justice in Environmental Matters (the Aarhus Convention, 1998),
as well as the UNECE Convention on Environmental Impact Assessment in a
Transboundary Context (the Espoo Convention, 1991) and its Protocol on Strategic
Environmental Assessment (the Kyiv Protocol, 2003).
11059/26 15
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(20) Land use conflicts can create barriers to the deployment of strategic projects. The relevant
national, regional or local authority responsible for preparing zoning, spatial and land use
plans should consider whether to introduce in these plans, where appropriate, certain
provisions related to strategic projects. Those plans have the potential to help balance the
public interest and common good, decreasing the potential for conflict and accelerating the
sustainable deployment of strategic projects in the Union.
(21) Given the capital-intensive nature of pharmaceutical production, including the
establishment or expansion or modernisation of manufacturing sites for critical medicinal
products, active substances, and key inputs, targeted financial support can play a crucial
role in incentivising production within the Union. To strengthen the security of supply of
critical medicinal products, and where private investment alone is not sufficient, financial
support of investments in manufacturing capacity within the Union may be justified.
Member States should be able to prioritise financial support for strategic projects that
address specific vulnerabilities in the supply chains, while ensuring that such support
complies with the Union’s State aid rules. For this purpose, specific guidance to clarify the
application of Union State aid rules to assist the Member States has been provided by the
Commission services and will be updated as necessary.
(21a) In order to enforce the supply commitments from the manufacturing sites that have
received public support, it is important that all available legal instruments and tools are
used. This, in particular, includes enforcement of related clauses in grants or award
agreements, or activation, when justified, of funding recovery mechanisms in
accordance with the applicable law and contractual terms.
(21b) Where the export of critical medicinal products manufactured in the Union leads to a
critical shortage or a risk of a critical shortage, all available legal instruments are to be
considered to ensure availability of these products to patients in the Union. This includes
Regulation (EU) 2015/479 of the European Parliament and the Council9.
9 Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March
2015 on common rules for exports (OJ L 83, 27.3.2015, p. 34, ELI:
http://data.europa.eu/eli/reg/2015/479/oj).
http://data.europa.eu/eli/reg/2015/479/oj
11059/26 16
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(22) Financial Support for strategic projects could be provided by the Union under Union
programmes in line with the objectives and provisions set out in the respective
regulations establishing those programmes. In particular, strategic projects should be
able to benefit from access to existing Union funding instruments, including the
EU4Health Programme10, the Digital Europe Programme11 and Horizon Europe12
(relevant, for example, for active substances referred to in ▌ Regulation (EU) 2021/695),
as well as the Strategic Technologies for Europe Platform (STEP), when they fulfil the
criteria established in these instruments. Authorities in charge of the Union programmes
covered by Regulation (EU) 2024/795 of the European Parliament and of the Council13
(STEP) should in particular consider supporting strategic projects addressing a
vulnerability in the supply chains of critical medicinal products and therefore Regulation
(EU) 2024/795 should be amended.
(22a) The strategic projects that received public financial support specifically to strengthen the
security of supply of critical medicinal products should prioritise supplies to the Union
market and ensure, within the limits of their responsibilities, supplies that cover needs of
patients in the Member States where those critical medicinal products have been placed
on the market.
10 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March
2021 establishing a Programme for the Union’s action in the field of Health (‘EU4Health
Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L
107, 26.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/522/oj).
11 Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021
establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L
166, 11.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/694/oj).
12 Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021
establishing Horizon Europe – the Framework Programme for Research and Innovation,
laying down its rules for participation and dissemination, and repealing Regulations (EU)
No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1, ELI:
http://data.europa.eu/eli/reg/2021/695/oj).
13 Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February
2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending
Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057,
(EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695,
(EU) 2021/697 and (EU) 2021/241 (OJ L, 2024/795, 29.2.2024, ELI:
http://data.europa.eu/eli/reg/2024/795/oj).
http://data.europa.eu/eli/reg/2021/522/oj
http://data.europa.eu/eli/reg/2021/694/oj
http://data.europa.eu/eli/reg/2021/695/oj
http://data.europa.eu/eli/reg/2024/795/oj
11059/26 17
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(23) To allow for a more coordinated approach to financial support, it is appropriate that
Member States and the Commission exchange ▌ information on financial support to
strategic projects. As regards the strategic projects that have received Union funding, it is
important that the beneficiaries ▌ follow the relevant communication and visibility rules.
(23a) Since the strategic projects are located in the territory of the Union, any public financial
support provided to establish, increase, modernise the manufacturing capacity for
critical medicinal products, their active substances or key inputs, should be spent within
the Union.
(24) Given that public authorities or entities are the principal buyers of medicinal products for
the inpatient sector and that the public procurement of medicinal products is a powerful
tool to improve security of supply ▌, it is necessary to establish rules that promote
resilience of supply in public procurement procedures of critical medicinal products
falling within the scope of Directive 2014/24/EU of the European Parliament and of the
Council15 through integration of resilience requirements, as appropriate, in the process
of public procurement in accordance with this Directive, in particular through
application of award criteria favouring the most economically advantageous tender
(MEAT) that take into account the supply security and availability considerations. In
addition, to provide market predictability and support investment in the production of
medicinal products, procurement procedures under this Regulation are to, where
justified, include predictable quantities. Those commitments can serve as an incentive
for manufacturers to maintain or scale up production capacity, particularly for
medicinal products that are essential for public health but might not be commercially
attractive under standard market conditions.
15 Directive 2014/24/EU of the European Parliament and of the Council of 26 February
2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p.
65, ELI: http://data.europa.eu/eli/dir/2014/24/oj).
http://data.europa.eu/eli/dir/2014/24/oj
11059/26 18
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(24a) In order to strengthen the resilience of supply chains for medicinal products and to
mitigate the risk of supply disruptions, procurement procedures carried out under this
Regulation should, where appropriate, allow for the award of contracts to multiple
suppliers for the same medicinal product. Such multi-winner procurement approaches
can promote diversification of supply, enhance security of supply, and ensure that
production capacity is distributed across different manufacturers and geographical
locations within the Union.
(24b) The resilience of supply is strengthened if diversified supply sources are available, as
diversification reduces a concentration of risk. Any dependence on only one supplier,
irrespective of whether established in the Union or outside the Union, threatens the
security of supply. Resilience requirements should therefore aim to support the
availability of alternative suppliers of active substances, but also should be able to relate,
inter alia, to stockholding obligations, timeliness of the delivery or management of the
supply chains. Contracting authorities in the Member States should retain flexibility to
decide the most relevant approach, given the market situation and their specific needs.
The resilience can be promoted throughout the procurement procedures, by integrating
those resilience requirements either in the selection criteria, technical specifications,
award criteria or in the contract performance clauses, depending on the market situation
and public health considerations. Active use of award criteria acknowledging quality
alongside price are essential levers.
(25) Across Member States, contracting authorities differ in their introduction and use of
resilience requirements in public procurement procedures, which lead to differentiated
practices. This could have a negative impact on the internal market as it creates obstacles
to cross-border participation and a lack of predictability for bidders. In order to avoid such
negative outcomes, the use of resilience requirements should be mandatory and a more
streamlined practice supported.
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(26) Where dependency on a single or a limited number of countries outside the Union is
threatening the security of supply, it is necessary to procure in a way that promotes
alternative supply options to ensure a high level of public health protection. For this
reason, and in order to support the diversification of suppliers, where a vulnerability
evaluation of critical medicinal product performed by the MSSG points to the
vulnerability resulting from a high level of dependency on a single or ▌ limited number of
third countries, ▌ the contracting authorities ▌ should apply the procurement requirements
that, while preserving competition, incentivise manufacturing in the Union. To ensure
flexibility necessary to accommodate different national procurement practices in the
Member States, the contracting authorities should be able to choose at least one from the
tools offered in this Regulation. Such procurement requirements could take the form of
award criteria relying on a scoring system that rewards the suppliers proportionally to
the volume of Union manufactured products offered and weighting attributed to
manufacturing in the Union that effectively incentivises it, with the possibility to provide
an extra reward for suppliers that offer more than 50 % of the contract volume
manufactured in the Union. In case contracting authorities consider several lots in the
procurement procedure, such requirements could also take form of technical
specifications reserving at least one lot, representing a significant percentage of the total
volume of the contract, to products manufactured in the Union. ▌
(26a) ▌ Member States’ responsibilities for the definition of their health policy and for the
organisation and delivery of health services and medical care, including the allocation of
financial resources, are to be respected, as referred to in Article 168(7) TFEU. The
contracting authorities should therefore retain the ability in exceptional cases, where
justified by ▌ considerations related to ▌ market circumstances or considerations related
to financing of health services, to adopt procurement approaches that differ from those set
out in this Regulation as long as they are in line with the Union’s international obligations.
11059/26 20
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(26b) Considering the complexity of the pharmaceutical value chain, the contracting
authorities, when assessing whether medicinal products and active pharmaceutical
substances have been manufactured in the Union, should be able to rely on claims and
evidence provided by the tenderers and should take into account manufacturing
steps that add the most value.
(26c) In order to incentivise investments in modernisation or establishment of new
manufacturing capacity in the Union for critical medicinal products for which a
vulnerability evaluation indicated a vulnerability resulting from the high level of
dependency on third countries, it is necessary that the industry operators have
predictable market conditions that would encourage investments. For this reason it is
important that the procurement requirements favouring manufacturing in the Union
apply as long as the medicinal product remains on the Union list of critical medicinal
products and is designated as vulnerable due to the high level of dependency and for a
minimum period of 5 years from the day of entry into force of the last implementing act
by which the medicinal product in question is specified as vulnerable due to the high
level of dependency.
(26d) The continuous availability of critical medicinal products is essential to preserve human
life and can be seriously threatened by the existence of a confirmed vulnerability of
supply to the Union, consisting of a high level of dependency on one or a few number of
third countries. The resilience requirements in procurement procedures aiming to
safeguard the availability of critical medicinal products should be applied subject to the
Union’s international commitments including the Government Procurement Agreement
in WTO and other relevant international agreements to which the Union is bound.
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(27) The application of procurement requirements in public procurement procedures should
take into account the specific market conditions and public health needs of each
procurement procedure, whilst bearing in mind the considerations related to affordability
of medicinal products. Certain procurement requirements might not be justified if they
result in disproportionate cost for procurers or discourage participation, leading to no bids,
or if no suitable tender or no requests to participate have been submitted in response to a
similar public procurement procedure launched by the same contracting authority in the
two years prior to the commencement of the planned new procurement procedure.
Contracting authorities can presume tenders whose price exceeds the contracting
authority’s budget, as determined and documented prior to the launching of the
procurement procedure, to be considered as tenders with disproportionate costs.
Similarly, certain requirements might not be justified where it is strictly necessary due to
reasons of extreme urgency brought about by events unforeseeable by the contracting
authority and where the circumstances invoked to justify extreme urgency are not
attributable to the contracting authority and make it impossible to comply with those
requirements in the specific context of a negotiated procedure without prior publication.
Such extreme urgency events can include major natural or public‑health emergencies
requiring immediate action to protect patients’ life and health. In all such cases, the
non-application of those requirements should be duly justified and exceptional.
▌
(29) The Commission should issue guidelines designed to support Member States and
contracting authorities in implementing and applying the resilience requirements in
public procurement, including the obligations to use resilience requirements and
requirements that favour critical medicinal products, or their active substances,
manufactured in the Union with a view to strengthening the security of supply. The
Commission should consult relevant stakeholders such as patients and consumer
organisations, healthcare professionals, public healthcare payers and marketing
authorisation holders, in the process of preparation of those guidelines.
11059/26 22
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(30) The procurement of medicinal products is organised differently across Member States,
involving various actors. To strengthen the security of supply chains for critical medicinal
products, Member States should establish national programmes that promote the consistent
use of requirements in public procurement procedures by contracting authorities within
their territory. Such national programmes could also promote the consistent use of multi-
winner approaches where beneficial, based on a thorough market analysis. To ensure a
comprehensive approach, and considering that critical medicinal products are also relevant
for the outpatient sector where they are often not purchased through public procurement,
those national programmes can also encompass other measures to strengthen supply chain
resilience and sustainability through measures related to pricing and reimbursement, where
appropriate. The programmes should be shared with the Commission and the Critical
Medicines Coordination Group (CMCG), established by this Regulation, to facilitate the
exchange of best practices and coordination between the Member States. This cooperation
should enhance the overall effectiveness of the various measures put forward to secure the
supply of critical medicinal products, while respecting the principles of subsidiarity and
proportionality.
(30a) In order to ensure legal clarity and effective coordination at Union level, it is essential to
distinguish between the concepts of contingency stocks and national stockpile. Those two
concepts refer to different types of reserves, governed by distinct legal and operational
frameworks, and serving different purposes within the supply chain and public health
preparedness In the context of contingency stocks, Member States should be encouraged
to require that the economic actors requested to hold contingency stocks apply
sustainable measures that contribute to reducing waste and improving the efficient use
of available medicinal products in line with national law and national needs.
11059/26 23
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(31) Some Member States impose obligations on marketing authorisation holders and other
economic operators in the pharmaceutical supply chain to healthcare providers and
patients to hold contingency stocks for the purpose of safeguarding the security of supply
of medicinal products within their territory. Contingency stocks are to be distinguished
from publicly owned national, regional or local stockpiling in order to anticipate and
manage a specific crisis. Contingency stocks requirements imposed by a Member State
can potentially have a ▌ negative impact on the internal market and result in
unavailability of the medicinal products concerned in other Member States. Any such
contingency stocks requirements are to take into account that any restriction to the free
movement of goods has to be justified, in accordance with the TFEU as interpreted by
the Court of Justice of the European Union. To avoid a negative impact on availability
of medicinal products, Member States should also, when introducing or changing
existing contingency stock requirements for any medicinal products, including when
determining the medicinal products covered, the size of required stocks and the timeline
for establishment of the stocks, take into consideration the principles of proportionality,
transparency and solidarity. ▌ Member States should give due consideration to
forthcoming Commission guidelines designed to facilitate the fulfilment of Member States’
obligations as regards compliance with the internal market and the free movement of
goods when proposing and defining contingency stock requirements ▌.
(31a) To support the identification of potential negative impacts of the national contingency
stock requirements, any Member State should notify the CMCG of its intention to impose
such requirements, as well as inform the CMCG of those requirements once adopted.
Such obligation should be without prejudice to the notification requirement under
Directive (EU) 2015/1535 of the European Parliament and of the Council16. To support
transparency of Member States contingency stock requirements, the Agency should
provide an overview of the imposed contingency stock requirements.
16 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9
September 2015 laying down a procedure for the provision of information in the field of
technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015,
ELI: http://data.europa.eu/eli/dir/2015/1535/oj).
http://data.europa.eu/eli/dir/2015/1535/oj
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(31b) It is important to fully leverage the Voluntary Solidarity Mechanism for medicinal
products to allow preventing negative consequences of critical shortages of critical
medicines to patients. Once the Voluntary Solidarity Mechanism for medicinal products
is activated, the MSSG should be able to request the data on the available stock of
critical medicinal products concerned, and if the Voluntary Solidarity Mechanism for
medicinal products does not result in a suitable option to address the request of a
Member State facing a shortage, the MSSG could issue recommendations.
(32) Availability and access disparities exist for critical medicinal products and medicinal
products of common interest throughout the Union, disproportionately affecting some
Member States. The collaborative procurement of critical medicinal products and of
medicinal products of common interest can be a powerful tool to improve their security of
supply and accessibility. The participation of the economic operators in collaborative
procurement procedures conducted pursuant to this Regulation should be voluntary.
(33) Directive 2014/24/EU ▌ provides for the possibility of procurement involving contracting
authorities from different Member States. Whereas it has been found helpful to make small
markets attractive for suppliers, thereby achieving better availability of medicinal products,
the implementation of that possibility is time- and resource-intensive, especially in the
procurement starting phase, and considered a limiting factor. To facilitate the deployment
of procurement initiatives involving contracting authorities from different Member States,
the Commission, when requested, should provide its assistance during the preliminary
phase of setting up such a procurement initiative. The Commission assistance should be
limited in time and should not concern the choices of procurement procedures, or of the
procurement requirements, selection of tenders or decision on inclusion of specific
contract elements. The involved Member States are able to agree to continue the
procedure without the Commission’s facilitation, including by agreement on another
facilitator in accordance with Directive 2014/24/EU. Any involved Member State can
withdraw from the procedure at any stage before the signature of the procurement
contract. Withdrawal by one Member State would not in itself affect the continuation of
the procedure by the remaining participating Member States, provided that the minimum
requirements under this Regulation are still met. Member States could specify that they
wish to conduct the cross-border procurement with candidate countries.
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(34) Taking into account experiences resulting from the implementation of joint procurement of
medical countermeasures pursuant to Regulation (EU) 2022/2371 of the European
Parliament and of the Council18, and of COVID-19 vaccines ▌ pursuant to Council
Regulation (EU) 2016/36919 in the context of the EU Vaccines Strategy, and
acknowledging potential benefits that leveraging of several Member States demand in one
procurement procedure might have, Member States should be able to consider ▌
requesting the Commission to procure on their behalf, or in their name, where such
procurement could contribute to the achievement of the objectives of this Regulation.
(35) To ensure that the collaborative procurement on behalf or in name of the Member States
contribute to the achievement of the objectives of this Regulation, while fully respecting
the principle of subsidiarity, the Commission’s involvement ▌ should be limited to ▌ cases
where the conditions set out in the relevant Articles are met. For this reason, derogation
from Article 168(3) of Regulation (EU, Euratom) 2024/2509 of the European Parliament
and of the Council20 should be provided.
18 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23
November 2022 on serious cross-border threats to health and repealing Decision
No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26, ELI:
http://data.europa.eu/eli/reg/2022/2371/oj).
19 Council Regulation (EU) 2016/296 of 15 March 2016 on the provision of the emergency
support within the Union (OJ L 70, 13.3.2016, p. 1, ELI:
http://data.europa.eu/eli/reg/2016/369/oj).
20 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23
September 2024 on the financial rules applicable to the general budget of the Union (OJ L,
2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).
http://data.europa.eu/eli/reg/2022/2371/oj
http://data.europa.eu/eli/reg/2016/369/oj
http://data.europa.eu/eli/reg/2024/2509/oj
11059/26 26
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(35a) It is not appropriate that the Commission conducts a collaborative procurement on
behalf of, or in the name of, the requesting Member States where it has substantiated
grounds to expect that the procedure will not contribute to the improvement of the
security of supply of critical medicinal products or the accessibility of medicinal products
of common interest, while at the same time contributing to their affordability, or where
there are substantiated concerns that the procedure could result in a restriction of
competition, a distortion of trade or discrimination against Member States that do not
participate in the initiative, or where the involvement of the Commission cannot be
justified in the light of the principles of utility, necessity and proportionality, and in this
context, concerns related to the efficient use of the Commission resources. The
Commission should therefore be able to refuse to conduct the procurement procedure on
these grounds.
11059/26 27
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(36) In accordance with Article 168 of Regulation (EU, Euratom) 2024/2509, the
Commission, when procuring on behalf or in the name of the Member States, is to act
only within the limits of the mandate given by the participating Member States. To
ensure transparency, legal clarity, and effective coordination, a structured agreement
between the Member States and the Commission should govern procurement procedures
under this Regulation that rely on an active Commission involvement. Such an agreement
should set out the division of responsibilities, decision-making processes, the information
to be shared as relevant to the procurement procedure, including information on Member
States’ participation in parallel negotiations through different channels in relation to the
same medicinal products or the same active substances as appropriate, and liability
provisions, ensuring a fair and efficient framework for participating Member States while
preventing market distortions and supply disruptions. This Regulation is without prejudice
to, and does not prevent the use of, joint procurement procedures established under
Regulation (EU) 2022/2371 ▌ for those critical medicinal products and other medicinal
products that also fall within the definition of medical countermeasures as set out in that
Regulation. ▌ This Regulation is without prejudice to Council Regulation (EU)
2022/237221 setting the framework of measures for ensuring the supply of crisis-relevant
medical countermeasures in the event of a public health emergency at Union level.
21 Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for
ensuring the supply of crisis-relevant medical countermeasures in the event of a public
health emergency at Union level (OJ L 314, p. 64, ELI:
http://data.europa.eu/eli/reg/2022/2372/oj).
11059/26 28
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(37) In order to ensure a structured and coordinated approach, as well as a coherent
information exchange, to strengthen the security of supply of critical medicinal products,
collaboration between the Member States, as well as between the Member States and the
Commission, is required. To that end, the CMCG should be established to facilitate
effective coordination across the relevant policy areas. The CMCG should be composed of
a permanent representative with strategic expertise in medicinal products procurement
policies, industrial policy related to pharmaceuticals and public health. As necessary,
Member States should be able to appoint additional expert representatives to accompany
the permanent Member State representative in order to support the different tasks of the
CMCG. The Commission should be a member of the CMCG. To ensure structured
discussions, a representative of the Member States and a representative of the
Commission should co-chair. The Agency should have an observer status. The
representatives of relevant stakeholders, including industry and patients’ representatives,
could, at the discretion of the CMCG, be invited by the CMCG to meetings to provide
expertise or participate as observers, where this is relevant and appropriate. The
Commission should perform the functions of the secretariat of the CMCG.
11059/26 29
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(38) To ensure coordinated implementation of this Regulation, the CMCG should enable
exchanges of information related to funding of strategic projects. The CMCG should also
facilitate the exchange of information on national programmes to promote best practices
and, where appropriate, voluntary cooperation on Member States public procurement
policies with regard to critical medicinal products. The CMCG should furthermore
facilitate discussions on ▌ collaborative procurement initiatives, exchanges on guiding
principles on contingency stock requirements, discussions on the need to prioritise the
vulnerability evaluation for specific critical medicinal products and serve as a forum for
discussion on other possible collaborative initiatives, such as reserving jointly a
manufacturing capacity for critical medicinal products, their active substances or key
inputs. The coordination work of the CMCG should be distinct from the work of the
MSSG established under Article 3 of Regulation (EU) 2022/123 and whose tasks are set
out in that Regulation (EU) 2022/123 and Regulation (EU) No …/… +. Whereas the
main tasks of the MSSG are to coordinate Union-level responses to actual or potential
shortages of medicinal products during public health emergencies or major events, to
monitor the supply and demand of critical medicines and to provide recommendations to
prevent or mitigate shortages and support the strengthening of security of supply of
critical medicinal products, the focus of the CMCG should be to facilitate coordination
of the measures envisaged in this Regulation creating the necessary conditions on
investments and public procurement coordination and collaboration to proactively
reduce dependencies and strengthen Union manufacturing capacity.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
11059/26 30
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(38a) In order to ensure the efficient use of resources and their sound management, as well as
the impact of public funding to support strategic projects, it is important that Member
States and the Commission establish channels for exchanging and coordinating on
relevant information. The CMCG should play a central role in facilitating such
exchanges between the Member States. The Commission should also provide the CMCG
with information on open calls intended to support the strategic projects under Union
funding instruments. Where applicable, further synergies should be ensured through
increased coordination at national level between CMCG members and Member States
representatives involved in the management of potentially relevant Union funding
(38b) The CMCG should facilitate discussions between interested Member States to explore
their interest in concluding joint reservation contracts of specific manufacturing
capacities. Whenever a joint reservation contract results in a necessity to increase or
modernise manufacturing capacity, such initiative should be recognised as a strategic
project and benefit from the advantages offered by this Regulation.
(39) The ▌ availability and security of supply of critical medicinal products is to be enhanced
through diversification of supply sources, including through access to alternative sources
of supply in third countries. Such access could be supported by existing international
▌agreements. In view of exploring the potential of mutually beneficial cooperation in the
area of critical medicinal products, the Commission could ▌ pursue new strategic
partnerships with third countries ▌, especially with candidate countries. In this context, the
Commission should assess ▌ what types of potential partnerships could be concluded with
the most relevant third countries. This should be done without prejudice to the prerogatives
of the Council under the Treaties.
11059/26 31
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(40) To ensure the application of this Regulation, it is necessary that market actors make
available information to the competent authorities ▌ and the Commission. The national
competent authorities, the Commission or the Agency, as relevant, must therefore be able
to request, when necessary and avoiding duplication of information requests, the
information necessary for the application of this Regulation. Furthermore, existing data
infrastructures and databases should be fully leveraged in order to reduce reporting
burdens, and improve the efficiency of data exchanges between competent authorities
and stakeholders. Market actors should be able to indicate that the information has
already been provided and is available to the requesting authority. Information acquired
in the course of implementing this Regulation should be protected by the relevant Union
and national law. An appropriate level of confidentiality of sensitive business
information and data obtained should be ensured in accordance with applicable Union
and national law. In particular, the staff of the Commission and the national competent
authorities should not disclose information acquired or exchanged by them pursuant to
this Regulation where such information is covered by the obligation of professional
secrecy. This should also apply to the CMCG. Any obligations on sharing information
pursuant to this Regulation should not apply to data that concern the essential interests
of the Member States’ security or defence.
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(41) In order to ensure that this Regulation effectively meets its objectives, it is essential to
assess its implementation and impact over time. The Commission should carry out an
evaluation of this Regulation at the latest five years after its application and every five
years thereafter. That evaluation should include an assessment of the extent to which the ▌
objectives of this Regulation, as set out in Article 1, have been achieved, including its
impact on stakeholders, regulatory procedures, and market dynamics. The evaluation
should also include an assessment of the scope, functioning and efficiency of Article 18,
as well as of the coherence of the Regulation with developments within the field of
public procurement. In particular, the Commission’s evaluation should take into account
the views of Member States, market actors, contracting authorities and other relevant
stakeholders, ensuring that their feedback contributes to the continuous improvement of the
regulatory framework. The results of the evaluation should be presented to the European
Parliament, the Council, the European Economic and Social Committee and the Committee
of the Regions. In order to facilitate that evaluation, national authorities, market actors,
contracting authorities and other relevant stakeholders should provide relevant data and
information upon request to support the Commission’s assessment.
(42) Since the objectives of this Regulation, namely to improve the functioning of the internal
market by establishing a framework to strengthen the availability and security of supply of
critical medicinal products within the Union and to improve the availability and
accessibility of medicinal products of common interest through coordinated and targeted
action of Member States, cannot be sufficiently achieved by the Member States acting
alone, but can rather, by reason of the scale of the action needed, be better achieved at
Union level, the Union may adopt measures in accordance with the principle of
subsidiarity, as set out in Article 5 of the TFEU. In accordance with the principle of
proportionality, as set out in that Article, this Regulation does not go beyond what is
necessary in order to achieve those objectives.
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HAVE ADOPTED THIS REGULATION:
Chapter I
General provisions
Article 1
Objectives and subject matter
1. The objective of this Regulation is to improve the functioning of the internal market by
establishing a framework to strengthen the security of supply and the availability of critical
medicinal products within the Union, thereby ensuring a high level of public health
protection, supporting the security of the Union and strategic autonomy and contributing to
patients’ safety. The objective of this Regulation is also to improve the availability and
accessibility of ▌ medicinal products of common interest where the functioning of the market
does not otherwise sufficiently ensure the availability and accessibility of those medicinal
products to patients, whilst giving due consideration to the ▌ affordability of those medicinal
products.
2. To achieve the objectives referred to in paragraph 1, this Regulation establishes a framework
to:
(a) facilitate, support and incentivise investments in new manufacturing capacity and
strengthen existing manufacturing capacity for critical medicinal products, as well
as their active substances and other key inputs in the Union, to increase the
resilience of the supply chains and to facilitate their sustainable availability to the
critical medicinal product producers;
(b) lower the risk of supply disruptions and strengthen availability by incentivising
supply chain diversification, reducing dependencies, in particular on third
countries, where these put the supply of critical medicinal products at risk, and by
fostering resilience in the public procurement procedures ▌;
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(ba) address shortages and strengthen availability of critical medicinal products by
facilitating coordination, transparency and solidarity among Member States with
regard to contingency stocks requirements;
(c) leverage the aggregated demand of participating Member States through
collaborative procurement procedures, and
(d) support the diversification of supply chains also by facilitating the conclusion of
strategic partnerships.
Article 2
Scope
1. This Regulation applies, with the exception of Article 21, to the critical medicinal products
listed in the Union list of critical medicinal products referred to in Article 137 of Regulation
(EU) …/… +. ▌
2. Articles 1, 21, 22 and 24, Article 26(2), point (c), and Article 26(5) also apply to medicinal
products of common interest. ▌
2a. Articles 1, 5 and 6, Article 8(1), point (c), Articles 12, 13 and 21, Article 22(1), point (b),
Article 22(1a) to (7), Article 24, Article 26(2), point (c), and Article 26(5) of this Regulation
also apply mutatis mutandis to orphan medicinal products and designated orphan
medicinal products, irrespectively of whether a given product is a critical medicinal product
as defined in Article 2, point (…), of Regulation (EU) …/… + or a medicinal product of
common interest as defined in Article 3, point (5), of this Regulation, as applicable.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)) and in the corresponding footnote the number, date of adoption and
publication reference of that Regulation, including its ELI number.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
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Article 3
Definitions
For the purposes of this Regulation, relevant definitions laid down in Article 4 of Directive (EU)
…/… ++ and in Article 2 of Regulation (EU) …/… + shall apply. The following definitions shall
also apply:
▌
(2) ‘key input’ means an input material other than an active substance required in the
manufacturing process of a given medicinal product, including immediate packaging
materials, excipients, solvents, reagents and starting materials;
▌
(3a) ‘collecting’ means collection of substances of human origin, as defined in Article 3,
point (1), of Regulation (EU) 2024/1938 of the European Parliament and of the
Council22, or of substances of animal origin for the purpose of being used as a starting
material for critical medicinal products;
▌
(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical
medicinal product, for which in three or more Member States the functioning of the market
does not sufficiently ensure the availability and accessibility to patients in the quantities
and presentations necessary to cover the needs of patients in those Member States;
++ OJ: please insert in the text the number of the Directive in document ST 7106/26
(2023/0132(COD)).
22 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June
2024 on standards of quality and safety for substances of human origin intended for
human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L,
2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj).
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(6) ‘vulnerability in the supply chains’ means risks and weaknesses within the supply chains
of critical medicinal products as evaluated in accordance with Article 136(1), point (b),
and Article 138(2), of Regulation (EU) …/… +;
(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal
products as carried out in accordance with Article 136 and Article 138(2) of Regulation
(EU) …/… +
▌
(9) ‘contracting authorities’ means contracting authorities as defined in Article 2(1), point (1),
of Directive 2014/24/EU;
(10) ‘strategic project’ means an industrial project recognised as a strategic project by a
designated authority as referred to in Article 6 pursuant to the criteria set out in Article 5;
(11) ‘project promoter’ means any undertaking or consortium of undertakings developing a
strategic project;
(12) ‘permit-granting process’ means a process covering all relevant permits to build, expand,
convert and operate a strategic project, including building, chemical and grid connection
permits and environmental assessments and authorisations where those are required and
encompassing all applications and procedures;
(13) ‘innovative manufacturing process’ means a novel manufacturing process or
manufacturing technology, or novel application of an existing manufacturing technology,
including ▌ decentralised manufacturing, continuous manufacturing, yield improvements
or chemistry or biotechnology processes that contribute to the environmental
performance of the production, and use of Artificial Intelligence, platform technologies
or 3D technologies in manufacturing;
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
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(13a) ‘contingency stocks requirement‘ means an obligation to hold stocks of certain
medicinal products, imposed by a Member State, by law, regulations or administrative
provisions, on marketing authorisation holders and other economic operators in the
supply chain of medicinal products to healthcare providers and patients, including
stockholding obligations in public procurement procedures;
(14) ‘Member States’ cross-border procurement’ means a procurement procedure initiated at
the request of Member States and involving contracting authorities from different
Member States pursuant to Article 39 of Directive 2014/24/EU;
(15) ‘procurement on behalf of or in the name of the Member States’ means a procurement
procedure initiated at the request of Member States and mandating the Commission to act
as a central purchasing body on behalf of, or in the name of, the requesting Member States,
as provided for in Article 168(3) of Regulation (EU, Euratom) 2024/2509 of the
European Parliament and of the Council;
▌
(17) ‘supplier’ means the manufacturer or marketing authorisation holder of finished dosage
forms, or manufacturer of key inputs or active substances;
(18) ‘strategic partnership’ means a commitment between the Union and a third country,
group of third countries or international organisations to increase cooperation related to ▌
critical medicinal products and their supply chains, that is established through a non-
binding instrument and which facilitates beneficial outcomes for both the Union and the
relevant third country, group of third countries or international organisation;
(18a) 'resilience of supply' means the ability of the supply chain to maintain a continuous and
demand-oriented supply of medicinal products, active substances and key inputs in the
Union, even during disruptions or external shocks.
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Chapter II
Strengthening the Union’s security of supply
Article 4
Cooperation between Member States and the Commission
▌
2. The Member States and the Commission shall work together to strengthen the security of
supply and continuous availability of critical medicinal products in the Union through
measures that take full advantage of the potential of the internal market.
3. The Commission shall support the coordinated efforts of the Members States.
Chapter III
Enabling conditions for investment
SECTION I
CRITERIA AND PROCEDURE FOR THE RECOGNITION OF STRATEGIC PROJECTS
Article 5
Strategic Projects
A project located in the Union and related to creating, modernising or increasing manufacturing
capacity shall be recognised as a strategic project if it meets at least one of the following criteria:
(a) it creates or increases manufacturing capacity, including through new technologies and
innovative manufacturing processes, for one or more critical medicinal products or for
collecting or manufacturing their active substances;
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(b) it modernises an existing manufacturing site for one or more critical medicinal products or
their active substances to ensure greater sustainability or increased efficiency;
(c) it creates or increases manufacturing capacity for key inputs necessary for the
manufacturing of one or more critical medicinal products or their active substances;
(d) it contributes to the roll-out in the Union of a technology that plays a key role in enabling
the manufacturing of one or more critical medicinal products, their active substances or
key inputs.
Article 6
Recognition of Strategic Projects
1. Each Member State shall designate an authority (‘the designated authority’) that shall assess
▌ whether an industrial project meets at least one of the criteria set out in Article 5 and is
therefore recognised as a strategic project.
A Member State may designate more than one authority.
1a. In order for a project to be recognised as a strategic project, a promoter of an industrial
project shall request the designated authority to assess whether the project is a strategic
project. The request shall contain justification and relevant evidence related to the
fulfilment of at least one of the criteria set out in Article 5. The designated authority shall
provide its conclusion to the project promoter without undue delay and in any event no
later than 20 days after the receipt of the request.
1b. The submission of a request for a project to be recognised as a strategic project as provided
for in paragraph 1a does not preclude the promoter of the project from simultaneously
initiating application procedures with other authorities for the permits needed for the
project.
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2. Member States shall communicate to the Commission ▌ the designated authorities for the
purposes of paragraph 1 of this Article and Article 16(2).
3. The Commission shall provide a simple, accessible, and user-friendly webpage for project
promoters on which at least the following elements shall be clearly listed:
(a) the contact details and other relevant information on the tasks of Member States’
designated authorities;
(b) information on dedicated Union support for strategic projects; and
(c) a standard template for the project promoter’s request referred in paragraph 1a
available in all official languages of the Union.
3a. The Commission shall adopt implementing acts to provide for the standard template
referred to in paragraph 3, point (c), of this Article. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article 30a.
4. Any other authority in the Member State ▌ that receives a request from a promoter
concerning Articles 8 to 14 shall rely on the decision of the designated authority pursuant to
paragraph 1 as to whether that given project is recognised as a strategic project ▌.
▌
SECTION II
FACILITATING ADMINISTRATIVE AND PERMIT-GRANTING PROCESSES
Article 7
Priority status of strategic projects
1. Strategic projects shall be considered as contributing to the security of supply of critical
medicinal products in the Union and, therefore, to be in the public interest.
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2. The Member States’ authorities shall ensure that the relevant permit-granting processes
related to strategic projects are carried out without delay, in particular by making available ▌
any form of accelerated procedures that exists in applicable Union and national law while
ensuring the quality and robustness of assessments.
2a. Member States shall take into account paragraph 1 for the purposes of identifying
‘protected customers’ as defined in Article 2, point (5), of Regulation 2017/1938 of the
European Parliament and of the Council 23.
Article 8
Administrative and technical support
1. Upon request of a project promoter, ▌ Member States' authorities shall provide to a strategic
project located on its territory ▌ the administrative support necessary to facilitate its timely
and effective implementation, including assistance in accordance with national law:
(a) with regard to the project promoter’s compliance with applicable administrative and
reporting obligations;
(b) with regard to informing the public, with the aim of increasing public acceptance of
the strategic project and, where relevant, facilitating the consultation of local
communities, organisations and social partners;
(c) to the project promoter along the permit-granting process.
2. When providing the administrative support and the assistance referred to in paragraph 1, the
Member State shall pay particular attention to small and medium size enterprises (SMEs),
small mid-cap enterprises (SMCs) and not-for-profit entities and, where necessary, establish
a dedicated channel for communication with them to provide guidance and respond to queries
related to the implementation of this Regulation.
23 Regulation 2017/1938 of the European Parliament and of the Council of 25 October
2017 concerning measures to safeguard the security of gas supply and repealing
Regulation (EU) No 994/2010 ELI: http://data.europa.eu/eli/reg/2017/1938/oj.
http://data.europa.eu/eli/reg/2017/1938/oj
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Article 9
Request for granting the status of highest national significance
1. A project promoter may request that their application for a permit is granted the status of the
highest national significance, when such a status exists in national law, and be treated
accordingly.
2. National authorities shall grant the status of the highest national significance to an application
for a permit without prejudice to obligations provided for in Union law.
Article 10
Procedures relating to dispute resolution
A project promoter may request that any dispute resolution procedure, litigation, appeal and
proceedings on judicial remedies related to the permit-granting process and the issuance of permits
for a strategic project in the Union before any national courts, tribunals or panels, including with
regard to mediation or arbitration, where they exist in national law, is treated as urgent if and to the
extent to which national law provides for such an urgency procedure. The applicable rights of
defence of individuals or of local communities shall be respected during such urgency procedure.
The project promoter shall participate in such urgency procedures, where applicable.
Article 11
Regulatory and scientific support from competent authorities for medicinal products
1. Upon request of a project promoter, a Member State’s competent authority for medicinal
products shall provide regulatory support to a strategic project located on its territory, where
relevant. Such support shall include administrative support for obtaining the necessary
authorisations from the competent authority.
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The Member State’s competent authority shall prioritise inspections to verify compliance
with Good Manufacturing Practices ▌ for the approval of new and extended manufacturing
sites and for the modernisation of the manufacturing sites ▌ in the context of the concerned
strategic project. Where appropriate a Member State may refer the promoter to request the
dedicated advice and assistance by the European Medicines Agency (‘the Agency’) in
accordance with paragraph 2.
2. Upon request of a project promoter, the ▌ Agency ▌ shall provide dedicated advice to assist
project promoters developing projects relying on innovative manufacturing processes. Where
this advice includes aspects related to Good Manufacturing Practices, the Agency shall
involve the relevant national competent authority for medicinal products in the provision of
this advice.
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Article 12
Environmental assessments and authorisation
1. A project promoter may request, where the obligation to assess the effects on the environment
arises simultaneously from two or more of Council Directive 92/43/EEC24, Directive
2000/60/EC of the European Parliament and of the Council25, Directive 2001/42/EC of the
European Parliament and of the Council26, Directive 2008/98/EC of the European Parliament
and of the Council27, Directive 2009/147/EC of the European Parliament and of the Council28,
Directive 2010/75/EU of the European Parliament and of the Council29, Directive 2011/92/EU
of the European Parliament and of the Council30 or Directive 2012/18/EU of the European
Parliament and of the Council31, that a coordinated or joint procedure fulfilling the
requirements of those Union legislative acts is applied. The application of the joint or
coordinated procedure shall not affect the content or quality of the environmental impact
assessment.
24 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and
of wild fauna and flora (OJ L 206, 22.7.1992, p. 7, ELI:
http://data.europa.eu/eli/dir/1992/43/oj).
25 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000
establishing a framework for Community action in the field of water policy (OJ L 327,
22.12.2000, p. 1, ELI: http://data.europa.eu/eli/dir/2000/60/oj).
26 Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on
the assessment of the effects of certain plans and programmes on the environment (OJ L
197, 21.7.2001, p. 30, ELI: http://data.europa.eu/eli/dir/2001/42/oj).
27 Directive 2008/98/EC of the European Parliament and of the Council of 19 November
2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI:
http://data.europa.eu/eli/dir/2008/98/oj).
28 Directive 2009/147/EC of the European Parliament and of the Council of 30 November
2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7, ELI:
http://data.europa.eu/eli/dir/2009/147/oj).
29 Directive 2010/75/EU of the European Parliament and of the Council of 24 November
2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334,
17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj).
30 Directive 2011/92/EU of the European Parliament and of the Council of 13 December
2011 on the assessment of the effects of certain public and private projects on the
environment (OJ L 26, 28.1.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2011/92/oj).
31 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the
control of major-accident hazards involving dangerous substances, amending and
subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1, ELI:
http://data.europa.eu/eli/dir/2012/18/oj).
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Under the coordinated procedure referred to in the first subparagraph, a competent authority
shall coordinate the various individual assessments of the environmental impact of a
particular project required by the relevant Directive.
Under the joint procedure referred to in the first subparagraph, a competent authority shall
provide for a single assessment of the environmental impact of a particular project required by
the relevant Directive.
2. Member States shall ensure that the competent authorities issue the reasoned conclusion
referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the environmental impact
assessment within 60 days of receiving all necessary information.
3. In exceptional cases, where the nature, complexity, location or size of the proposed project so
requires, Member States may extend the time limit referred to in paragraph 2 once by a
maximum of 15 days, before its expiry and on a case-by-case basis. In that event, the
competent authority shall inform the project promoter in writing of the reasons justifying the
extension and of the deadline for its reasoned conclusion.
4. The deadlines for consulting the public concerned as referred to in Article 1(2), point (e), of
Directive 2011/92/EU and the authorities referred to in Article 6(1) of that Directive on the
environmental impact assessment report referred to in Article 5(1) of that Directive shall not
be longer than 85 days and not shorter than the 30 day period referred to in Article 6(7) of that
Directive.
5. With regard to the environmental impacts or obligations referred to in Article 4(7) of
Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC and Articles 6(4) and
16(1) of Directive 92/43/EEC, and for the purposes of Article 4(14) and (15) and Article
5(11) and (12) of Regulation (EU) 2024/1991, strategic projects in the Union may be
considered to have an overriding public interest and to serve the interests of public health and
safety provided that all the conditions set out in those acts are fulfilled.
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Article 13
Planning
1. National, regional and local authorities responsible for preparing plans, including zoning,
spatial plans and land use plans, shall consider including in such plans, where appropriate,
provisions for the development of Strategic Projects, as well as the necessary infrastructure.
To facilitate the development of strategic projects, Member States shall ensure that all
relevant spatial planning data are available and accessible.
2. Where plans including provisions for the development of strategic projects are subject to an
assessment pursuant to Directive 2001/42/EC of the European Parliament and of the Council
and pursuant to Article 6(3) of Directive 92/43/EEC, those assessments shall be combined.
Where applicable, the combined assessment shall also address the impact on potentially
affected water bodies referred to in Directive 2000/60/EC. Where Member States are required
to assess the impacts of existing and future activities on the marine environment, including
land-sea interactions, in accordance with Article 4 of Directive 2014/89/EU of the European
Parliament and of the Council32, the combined assessment shall also cover those impacts. The
fact that assessments are combined pursuant to this paragraph shall not affect their
content, or quality or robustness of the assessment.
32 Directive 2014/89/EU of the European Parliament and of the Council of 23 July 2014
establishing a framework for maritime spatial planning (OJ L 257, 28.8.2014, p. 135, ELI:
http://data.europa.eu/eli/dir/2014/89/oj).
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Article 14
Applicability of UNECE Conventions
1. This Regulation is without prejudice to the obligations under the United Nations Economic
Commission for Europe (UNECE) Convention on Access to Information, Public Participation
in Decision-making and Access to Justice in Environmental Matters, signed at Aarhus on 25
June 1998, and under the UNECE Convention on environmental impact assessment in a
transboundary context, signed at Espoo on 25 February 1991 and its Protocol on Strategic
Environmental Assessment, signed in Kyiv on 21 May 2003.
2. All decisions adopted pursuant to the Articles in this Section, to which the obligations under
the UNECE Convention apply, shall be made publicly available.
SECTION III
FINANCIAL INCENTIVES
Article 15
Financial support by Member States
1. Without prejudice to Articles 107 and 108 of the Treaty on the Functioning of the European
Union (TFEU), Member States may prioritise financial support to strategic projects that
address a vulnerability in the supply chains of critical medicinal products identified following
a vulnerability evaluation and with due consideration to the strategic orientations of the
Critical Medicines Coordination Group (‘CMCG’) referred to in Article 26(2), point (a).
1a. The Commission shall facilitate the consistent application of this Article by providing
sufficient guidance to Member States on the possibilities offered under existing State aid
rules for the granting of State aid to strategic projects.
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2. For as long as the critical medicinal product is on the Union list of critical medicinal products,
an undertaking that has benefitted from financial support by a Member State for a strategic
project shall prioritise ▌ the Union market ▌ to ensure, within the limits of its
responsibilities, appropriate and continued supply so that the needs of patients are covered
and the critical medicinal product remains available in the Member States on whose market it
has been made available.
Where appropriate, the terms of the financial support shall stipulate for how long the
obligation to prioritise the Union market shall continue to apply in case the critical
medicinal product is removed from the Union list of critical medicinal products.
3. The Member State that provided financial support to a strategic project may require the
beneficiary undertaking to prioritise supply and provide the necessary supplies of a critical
medicinal product, active substance or key inputs, as applicable, to the Union market to avoid
shortages in one or more Member States.
Any other Member State that encounters a threat of shortages of the critical medicinal product
in question may request the Member State that provided financial support to submit a request
on its behalf. The beneficiary undertaking shall make best efforts to supply such products in
the requesting Member State.
Article 16
Financial support from the Union
1. Financial support for strategic projects under the Multiannual Financial Framework 2021-
202733 may be provided by the Union from Union programmes, including, but not limited to,
the EU4Health Programme established by Regulation (EU) 2021/522, Horizon Europe
established by Regulation (EU) 2021/695, and the Digital Europe Programme established by
Regulation (EU) 2021/694, provided that such financial support is in line with the objectives
set out in the respective regulations establishing those programmes.
33 Council Regulation (EU, Euratom) 2020/2093 laying down the multiannual financial
framework for years 2021 to 2027 (OJ LI 433, 22.12.2020, p.11, ELI:
http://data.europa.eu/eli/reg/2020/2093/oj).
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1a. Where a project promoter receives financial support for a strategic project from a Union
financial instrument which provides that funding may be made available under the
condition of strengthening the availability of critical medicinal products consistent with the
objectives of this Regulation, it shall prioritise supply to the Union market and shall ensure,
within the limits of its responsibilities, that the critical medicinal product remains available
in the Member States in whose market it has been made available.
2. Where the strategic project relates to critical medicinal products for which the vulnerability
evaluation has been concluded, at the request of a project promoter, justified by the necessity
to demonstrate that a strategic project addresses a vulnerability in the supply chains as
necessary for the purpose of an application of Union funding, the designated authority shall
verify whether a strategic project addresses a vulnerability in the supply chains identified
following the vulnerability evaluation. The designated authority shall provide the verification
to the project promoter within 15 working days of receiving the request. The designated
authority shall inform the Commission about the strategic projects identified as addressing an
existing vulnerability in the supply chains without delay.
Where the designated authority considers that the submitted particulars and documents
accompanying the request referred to in the first subparagraph are incomplete, it shall
inform the project promoter accordingly and shall set a time-limit for providing the missing
information and documents. In case the designated authority sets such a time-limit, the
time-limit referred to in the first subparagraph shall be suspended until the missing
information and documents required have been provided.
2a. A financial allocation may also be made available from the general budget of the Union.
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Article 17
Exchange of information on financial support for strategic projects
1. Member States shall, without prejudice to their right to decide whether to provide financial
support to strategic projects, inform the CMCG, referred to in Article 25, of the intention to
provide such financial support sufficiently in advance to enable the CMCG to carry out its
coordination task as set out in Article 26.
2. The Commission and Member States shall regularly inform the CMCG of the strategic
projects receiving financial support from the Union and Member States respectively to
enable the CMCG to carry out its coordination task.
2a. When informing the Critical Medicines Group pursuant to paragraphs 1 and 2, Member
States shall include information on how the strategic projects concerned meet one or more
of the criteria listed in Article 5.
3. The Commission shall inform the CMCG about all open calls to support strategic projects.
It may inform the CMCG of its intention to propose the establishment of funding possibilities
and any other Union funding programmes that could benefit the availability of critical
medicinal products, under specific rules and conditions of those Union funding programmes.
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Chapter IV
Demand side measures
SECTION I
REQUIREMENTS FOR PUBLIC PROCUREMENT PROCEDURES AND RELATED MEASURES
Article 18
Incentivising resilience, sustainability and positive social impacts in public procurement procedures
1. For public procurement procedures of critical medicinal products falling within the scope of
Directive 2014/24/EU ▌, contracting authorities ▌ shall apply ▌ requirements that effectively
promote the resilience of supply in the Union for those critical medicinal products
('resilience requirements').
The resilience requirements shall support the diversification of supply sources of active
substances and, where applicable, medicinal products, including within the Union, and
reward reliable and compliant suppliers. In addition, the resilience requirements may, inter
alia, relate to stockholding ▌, ▌ timely delivery and management of the supply chains.
The resilience requirements shall be implemented by at least one of the following:
(a) selection criteria within the meaning of Article 58 of Directive 2014/24/EU; or
(b) technical specifications within the meaning of Article 42 of Directive 2014/24/EU;
or
(c) best price-quality ratio as contract award criteria within the meaning of Article 67
of Directive 2014/24/EU; or
(d) contract performance clauses within the meaning of Article 70 of Directive
2014/24/EU.
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2. For public procurement procedures of critical medicinal products for which a vulnerability
in the supply chains has been identified through a vulnerability evaluation pointing to the high
level of dependency on a single or a limited number of third countries, the contracting
authorities shall ▌ favour manufacturing of such medicinal products in the Union. ▌
To favour manufacturing of critical medicinal products in accordance with the first
subparagraph, the contracting authorities shall apply at least one of the following
mechanisms:
(a) use technical specifications within the meaning of Article 42 of Directive
2014/24/EU requiring that at least one lot representing at least 50 % percent of the
total volume covered by all lots is reserved for the suppliers offering the critical
medicinal product and its active substance manufactured in the Union when
applying multi-winner approaches in procurement procedures; or
(b) apply the best price-quality ratio as award criterion within the meaning of Article
67 of Directive 2014/24/EU and favour suppliers of critical medicinal products and
their active substances manufactured in the Union by applying a scoring that
proportionately rewards the share of manufacturing in the Union and by applying
a weighting that effectively achieves this objective. In this context, the contracting
authority may allocate additional points to the manufacturer who offers 50% or
more of the critical medicinal products and their active substances manufactured
in the Union.
The procurement requirements shall be applied in compliance with the Union’s
international commitments.
For the purpose of applying this paragraph, manufacturing in the Union shall include
manufacturing steps that are carried out within the Union other than import, repackaging,
packaging other than immediate packaging, labelling, quality testing and, where
applicable, certification.
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Evidence supporting the claim in tenders that the manufacturing is taking place in the
Union shall be provided where required by the tenderers, and supported by documents
facilitating the independent verification by the contracting authority.
2a. The procurement requirements referred to in paragraph 2 shall apply for as long as the
medicinal product remains on the Union list of critical medicinal products and is
designated as vulnerable due to the high level dependency and for a minimum period of 5
years from the date of entry into force of the last implementing act by which the medicinal
product in question is specified by the Commission as being vulnerable due to the high level
of dependency in accordance with Article 137(3) of Regulation (EU) …/…+.
3. For the purposes of paragraphs 1 and 2, the contracting authorities ▌ shall consider, where
appropriate, multi-winner approaches.
4. This Article shall not preclude contracting authorities from using additional qualitative
requirements, including requirements related to environmental sustainability and social
rights.
5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 2a and 3 where
it is duly justified by market circumstances or considerations related to the financing of
health services, where:
(a) the required critical medicinal product can only be supplied by a specific economic
operator as defined in Article 2(1), point (10), of Directive 2014/24/EU and no
reasonable alternative or substitute exists, and the absence of competition is not
the result of an artificial narrowing down of the parameters of the public
procurement procedure;
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
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(b) no suitable tenders or no suitable requests to participate have been submitted in
response to a similar public procurement procedure launched by the same
contracting authority in the two years prior to the commencement of the planned
new procurement procedure;
(c) the application of paragraphs 1, 2, 2a and 3 would oblige the contracting authority
to acquire critical medicinal products having disproportionate costs; or
(d) in the context of a negotiated procedure without prior publication pursuant to
Article 32(2), point (c), of Directive 2014/24/EU.
5a. The justification for the exceptions referred to in paragraph 5 specifying the relevant
circumstances or considerations shall be documented in writing by the contracting
authority and be subject to verification and redress where relevant.
6. By ... [12 months from the date of entry into force of this Regulation], the Commission shall
issue guidelines designed to support Member States in implementing the obligations of this
Article and to facilitate the compliance with those obligations by contracting authorities.
Article 19
National programmes supporting ▌ resilience in public procurement procedures
1. By ... [12 months from the date of entry into force of this Regulation], each Member State
shall, with due respect to the organisation of the procurement of medicinal products within
the Member State, establish a national programme supporting security of supply of critical
medicinal products, including in public procurement procedures. Such programmes shall
promote the consistent use of procurement requirements by contracting authorities within a
given Member State as well as multi-winner approaches, where beneficial in light of the
market analysis. Such programmes may also include measures for pricing and reimbursement
supporting security of supply of those critical medicinal products that are not purchased
through public procurement procedures. Member States may involve their national pricing
and reimbursement authorities in the planning and evaluation of such programmes.
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2. Member States shall inform the Commission in its role of the secretariat of the CMCG about
their programmes. The Commission shall ensure the distribution to all members of the
CMCG forthwith. The CMCG shall facilitate a discussion, aiming to ensure coordination of
national programmes including as regards the application of the procurement requirements
referred to in Article 18(2) and may issue opinions. Where the CMCG issues an opinion
concerning the national programmes, Member States ▌ may take it into account when
revising their programmes.
Article 20
Safeguards related to Member States’ contingency stock requirements and other security of supply
measures
1. Contingency stock requirements applied in one Member State shall not result in any negative
impact in other Member States by respecting the principles referred to in paragraph 2 of this
Article.
Member States shall, in particular, avoid such an impact when proposing and defining the
scope and timing of any form of requirements for companies to hold contingency stocks.
2. Member States shall ensure that any contingency stock requirements, including the
implementation timeline, they impose on economic operators in the supply chain, are
targeted and respect the principles of proportionality, transparency and solidarity.
2a. This Article is without prejudice to obligations under Union law for the notification of
technical regulations and technical barriers to the internal market, including those laid
down in Directive (EU) 2015/1535.
2b. All contingency stock requirements and other security of supply measures shall be
implemented in a way that aims to minimise waste of medicinal products through effective
stock rotation based on the ‘first expired, first out’ system to prevent the destruction of
medicinal products.
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2c. The Commission shall, following a consultation with relevant stakeholders, including
patient and consumer organisations, healthcare professional organisations, public
healthcare payers, and industry representatives, issue Union guidelines for contingency
stocks. Those guidelines may include:
(a) best practices, reviewed regularly, for the setting of contingency stocks;
(b) recommended strategies for timely deployment of contingency stocks, including
labelling and packaging arrangements;
(c) best practices on sustainable contingency stock management and disposal of
medicinal products.
Article 20a
Information sharing and reporting on contingency stock requirements
1. Member States shall, without prejudice to their right to decide to impose contingency stock
requirements, inform the CMCG of their intention to impose such requirements or make
significant changes to such existing requirements, and inform of any such requirements
once imposed or of any such changes once made, for the purpose of transparency and to
enable exchanges on the guiding principles of proportionality and solidarity referred to in
Article 20(2).
2. This Article is without prejudice to obligations under Union law for the notification of
technical regulations and technical barriers to the internal market, including those laid
down in Directive (EU) 2015/1535.
3. The Agency shall establish and maintain a digital platform which provides an overview of
contingency stock requirements imposed by national law including which critical medicinal
products are covered and the size of required stocks.
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4. Where The European Voluntary Solidarity Mechanism for medicinal products is activated
in accordance with Article 131 of Regulation (EU) …/… +, Member States shall, where
reasonably possible within their national monitoring systems, upon request from the
MSSG, provide up-to-date stock data relating to critical medicinal products subject to
contingency stock requirements, which a Member State identifies as available for
reallocation.
5. Where the activation of the Voluntary Solidarity Mechanism for medicinal products has not
resulted in a suitable option to address that request, the MSSG may, at the request of the
Member State that activated that Mechanism, issue a recommendation to Member States
with the aim of facilitating contributions by marketing authorisation holders to that
Mechanism.
Such recommendation may, where appropriate, invite Member States to consider
suspending or adapting contingency stock requirements and related enforcement measures,
in order to enable the supply of the concerned critical medicinal product to Member States
facing a shortage and ensuring an optimal allocation of critical medicinal products
between the Member States.
6. Article 29a(4) shall apply to any information sharing and reporting under this Article.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)) and in the corresponding footnote the number, date of adoption and
publication reference of that Regulation, including its ELI number.
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SECTION II
VOLUNTARY COLLABORATIVE PROCUREMENTS
Article 21
Commission facilitated Member States’ cross-border procurement
1. Upon a reasoned request from three or more Member States (‘the request’), the Commission
may act as facilitator for the requesting Member States’ cross-border procurement as laid
down in Article 39 of Directive 2014/24/EU34 where the procurement concerns medicinal
products of common interest.
2. Having received the request, the Commission shall inform all other Member States of the
request, through the CMCG, and set ▌ a deadline of 4 weeks for Member States to declare
their interest in participating in the procedure.
3. The Commission shall assess the request in light of the objectives of this Regulation. The
Commission shall inform the interested Member States of its decision on whether it agrees ▌
to facilitate the proposed request within 15 working days following expiry of the deadline
specified in paragraph 2.
4. Where the Commission declines the request, it shall state its reasons for the refusal.
5. Where the Commission accepts the request, the Commission shall provide secretarial and
logistical support to the participating Member States. The Commission shall facilitate
communication and cooperation between the ▌ Member States and provide advice on
applicable Union public procurement rules, including on the use of procurement
requirements as set out in Article 18 and on regulatory matters related to medicinal products.
34 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014
on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65,
ELI: http://data.europa.eu/eli/dir/2014/24/2024-01-01 ).3
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6. The facilitation offered by the Commission shall be limited in time and shall end at the latest
upon signature of the procurement contract by the participating contracting authorities.
Member States participating in the cross-border procurement shall procure at their cost
only.
7. The Commission shall not be responsible, nor held liable, for any breaches of Union or
national procurement laws by the participating contracting authorities. The Commission shall
bear no liability associated with the conduct of the procurement procedure by participating
Member States or for the implementation of the contract resulting from the procedure.
7a. Member States may specify that they wish to conduct the cross-border procurement as
referred to in paragraph 1 with those candidate countries that choose to participate in the
procedures established herein and with which the Union has entered into a bilateral
agreement thereof, without prejudice to their accession negotiations or to the rights and
obligations reserved to Member States under Union law. The participation of candidate
countries shall not affect the need for three or more Member States to initiate the
procedure.
Article 22
Commission procurement on behalf of or in the name of Member States
1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509, where
five or more Member States jointly request the Commission to procure on their behalf ▌ or in
their name and at their costs (`the joint request`), the Commission shall, unless it provides
substantiated reasons not to initiate the procurement procedure, initiate such a procedure
under the conditions laid down in this Article when the procurement concerns medicinal
products belonging to one of the following categories:
(a) critical medicinal products for which a vulnerability evaluation has identified a
vulnerability in the supply chains or for which the MSSG has recommended a
common procurement initiative;
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(b) medicinal products of common interest, for which a joint clinical assessment report
has been published pursuant to Article 12(4) Regulation 2021/2282/EU 18, or which
have undergone a clinical assessment carried out under the voluntary cooperation
among Member States pursuant to Article 23(1), point (e), of that Regulation.
1a. The Commission may, on its own initiative, invite Member States to submit a joint request
in accordance with paragraph 1.
2. The joint request referred to in paragraph 1 shall only be submitted where the medicinal
product concerned fulfils one of the criteria laid down in that paragraph and where the
requested procurement procedure is expected to improve the security of supply and
availability of critical medicinal products in the Union or to ensure the availability and
accessibility and contribute to affordability of medicinal products of common interest, as
applicable.
3. The participation in the procurement procedure shall be open to all Member States. Having
received the joint request, the Commission shall inform all other Member States of the joint
request, through the CMCG, and set a deadline of four weeks for Member States to express
their interest in participating in the procedure.
4. The Commission shall assess ▌ whether the joint request is justified in light of the objectives
of this Regulation. The Commission shall in particular verify whether the procurement could
result in discrimination or restriction on trade or a distortion of competition taking into
account the utility, necessity and proportionality of the joint request.
5. Within 15 working days following expiry of the deadline in paragraph 3, the Commission
shall communicate to the interested Member States ▌ its decision and state its reasons in case
of a refusal.
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5a. The procurement procedures under this Article shall apply, where relevant, resilience
requirements equivalent to those set out in Article 18. Those requirements shall be specified
in accordance with Regulation (EU, Euratom) 2024/2509 and specified in the mandate
given by the participating Member States to the Commission within the meaning of Article
168(3) of that Regulation.
6. The initiation of the procurement procedure by the Commission shall be conditional upon
the interested Member States accepting binding minimum quantities, in accordance with
their national need, and may be conditional, if necessary ▌ in order to achieve the objectives
of this Regulation, upon the interested Member States refraining from participating in
competing subsequent procurement processes. Such a procurement procedure may only be
initiated once these conditions have been accepted by the interested Member States.
7. Except for the derogations provided for in this Regulation, the procurement referred to in this
Article shall be carried out in accordance with Article 168(3) of Regulation (EU, Euratom)
2024/250935.
▌
Article 24
Agreement concerning procedures under Article 22
1. Member States participating in the procurement procedures under Article 22 shall share with
the Commission any information relevant for the procurement procedure. The participating
Member States shall provide the resources necessary for the successful conclusion of the
procedure, in particular through involvement of staff with expertise and knowledge.
35 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of
23 September 2024 on the financial rules applicable to the general budget of the Union
(recast) (OJ L, 26.9.2024, p. 1, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).
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2. An agreement between the Member States and the Commission shall determine the practical
arrangements governing the procurement procedure, liabilities to be assumed and the
decision-making process. The procedure shall be carried out in accordance with the
mandate given by the Member States to the Commission as required by Article 168(3) of
Regulation (EU, Euratom) 2024/2509.
Chapter V
Critical Medicines Coordination Group
Article 25
Establishment of Critical Medicines Coordination Group
1. A Critical Medicines Coordination Group (‘CMCG’) is hereby established.
2. The Member States and the Commission are Members of the CMCG. Each Member State
shall appoint one permanent representative, with strategic expertise relevant for
implementing ▌ the different measures set out in this Regulation. As necessary, Member
States may appoint an alternate permanent representative and additional expert
representatives to accompany the permanent Member State representative in order to
support the different tasks of the CMCG. The Agency shall have an observer status.
The representatives of relevant stakeholders, including industry and patients’
representatives, may, at the discretion of the CMCG, be invited to meetings to provide
expertise or participate as observers, where this is relevant and appropriate.
2a. The representatives appointed to the Critical Medicines Group and its working group or
working groups shall make a declaration of their financial and other interests and update it
annually and whenever necessary.
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3. The CMCG shall work closely with the MSSG, the Agency ▌ and national competent
authorities ▌ for medicinal products. For discussions where input from national regulatory
authorities responsible for medicinal products is necessary, the CMCG and the MSSG may
organise joint meetings. To fulfil its tasks, the CMCG shall, where relevant, also consult
through joint meetings with patient and consumer organisations, healthcare professional
organisations and industry representatives.
4. The Commission, acting as the Secretariat of the CMCG, shall organise regular meetings
and coordinate the work of the CMCG. The CMCG shall establish its rules of procedure,
including procedures relating to the working group referred to in paragraph 6.
5. The CMCG shall be co-chaired by a representative of the Commission and by a
representative of the Member States, who shall be elected by and from among the
representatives of the Member States.
6. The CMCG, at the proposal of the co-chair or any of its members, may, on a case-by-case
basis, decide to establish one or more working groups.
7. The CMCG shall use its best endeavours to reach consensus, where possible, when providing
advice as referred to in Article 26(1), when providing recommendations as referred to in
Article 26(2), point (d), and when providing an opinion as referred to in Article 26(5). If
such consensus cannot be reached, the CMCG shall issue its position by a majority of two-
thirds of its members. Each Member State shall have one vote. Members with diverging
positions may request that their positions and the grounds on which they are based be
recorded in the CMCG’s position.
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Article 26
Tasks of the Critical Medicines Coordination Group
1. The CMCG shall facilitate coordination in the implementation of this Regulation, including,
where appropriate, by providing advice to the Commission or Member States at their
request, so as to maximise the impact of the measures envisaged and to avoid any unintended
effects on the internal market or on national healthcare systems.
2. In order to attain the objectives referred to in paragraph 1, the CMCG shall perform the
following tasks:
(a) facilitate coordination on strategic orientation of the financial support for strategic
projects, including by exchanging information, where available, on the
manufacturing capacity for a given critical medicinal product, existing or planned, in
the Member States, and facilitate discussion on the capacity needed in the Union to
strengthen its supply security and availability of critical medicinal products, their
active substances and key inputs within the Union;
(aa) enable the exchanges of information between the Member States and the
Commission as referred to in Article 17 and, where necessary, facilitate
coordination of respective actions aiming to attain the objectives of this
Regulation;
(b) facilitate exchanges on the national programmes referred to in Article 19, promote
best practices and enable cooperation on, and coordination of, Member States public
procurement policies with regard to critical medicinal products;
(ba) facilitate exchanges of information on contingency stock requirements as referred
to in Article 20a(1);
(c) facilitate discussion on collaborative procurement initiatives;
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(d) provide recommendations to the MSSG on the order of priority of critical medicinal
products for vulnerability evaluation as set out in Regulation (EU) …/… +, and
propose a review or an update of existing evaluations where necessary;
(da) regularly discuss the potential contribution of strategic partnerships to the objectives
of this Regulation ▌ and the consistency and potential synergies between Member
States’ cooperation with relevant third countries and the actions carried out by the
Union;
(db) facilitate exchanges among Member States in order to explore interest in joint
reservation contracts;
(dc) enable strategic foresight discussions among Member States and stakeholders
taking into account long-term trends, vulnerabilities, opportunities for enhancing
the resilience and sustainability of supply chains of critical medicines within the
Union.
5. The CMCG, at the Commission’s or Member State's request, may provide an opinion on
matters related to the application of this Regulation in the context of performing tasks as
referred to in this Article.
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)) and in the corresponding footnote the number, date of adoption and
publication reference of that Regulation, including its ELI number.
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Chapter VI
International cooperation
Article 27
Strategic partnerships
Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of
concluding strategic partnerships aiming to support the diversification of sources of supply of
critical medicinal products, their active substances and key inputs to increase the security of supply
of critical medicinal products in the Union. Such potential strategic partnerships may take the
form of dialogues on industrial, regulatory and policy matters, arrangements for stakeholders’
meetings or for experts’ exchanges.
The Commission shall also explore the possibility of building on existing forms of cooperation,
such as free trade agreements or association agreements, and in particular with candidate
countries where possible and appropriate, in order to support security of supply and reinforce
efforts to strengthen the production of critical medicinal products in the Union or diversification of
the supply sources. The Commission shall regularly inform the CMCG about their ongoing
considerations and assessments.
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Chapter VII
Amendments to Regulation (EU) 2024/795
Article 28
Regulation (EU) 2024/795 is amended as follows:
(a) in Article 2(1), point (a) ▌ (iii), is replaced by the following:
‘(iii) biotechnologies, and any other technologies relevant for manufacturing of critical
medicinal products as defined in Article 2, point (...), of Regulation (EU) .../…+*;
_________
* Regulation (EU) …/… of the European Parliament and of the Council laying down
Union procedures for the authorisation and supervision of medicinal products for
human use and establishing rules governing the European Medicines Agency, ▌
amending Regulations (EC) No 1394/2007 and Regulation (EU) No 536/2014 and
repealing Regulations (EC) No 141/2000 , (EC) No 726/2004, Regulation (EC)
No 141/2000 and Regulation (EC) No 1901/2006.’
(b) in Article 2, the following subparagraph is added in paragraph 3:
‘By way of derogation from the first subparagraph of this paragraph, the value chain for
the development or manufacturing of medicinal products that fall within the scope of the
[Critical Medicines Act] and that are referred to in paragraph 1, point (a)(iii), of this
Article, ▌ relates to finished dosage forms, as well as to active pharmaceutical ingredients
and other key inputs necessary for the production of the finished dosage forms of critical
medicinal products as defined in that Regulation.;’
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
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(c) in Article 2, paragraph 8 is added:
‘8. Strategic projects designated in accordance with the [Critical Medicines Act] that
address a vulnerability in the supply chains of critical medicinal products shall be
deemed to contribute to the STEP objective referred to in paragraph 1, point (a)(iii).;’
(d) in Article 4, paragraph 7 is replaced by the following:
‘7. Strategic projects recognised in accordance with the relevant provisions of the Net-
Zero Industry Act, the Critical Raw Materials Act [and the Critical Medicines Act]
that fall within the scope of Article 2 of this Regulation and that receive a
contribution under the programmes referred to in Article 3 of this Regulation may
also receive a contribution from any other Union programme, including funds under
shared management, provided that those contributions do not cover the same costs.
The rules of the relevant Union programme shall apply to the corresponding
contribution to the strategic project. The cumulative funding shall not exceed the
total eligible costs of the strategic project. The support from the different Union
programmes may be calculated on a pro rata basis in accordance with the documents
setting out the conditions for support.;’
(e) in Article 6, paragraph 1, point c is replaced by the following:
‘(c) details of projects that have been recognised as strategic projects under the Net-Zero
Industry Act, the Critical Raw Materials Act and the [Critical Medicines Act], to the
extent that they fall within the scope of Article 2 of this Regulation.’
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Chapter VIII
Final provisions
Article 29
Obligation of the market actors to provide information
1. For the purposes of Articles 6 and 8, Article 11(1), Articles 12 and 15, Article 16(2) and
Article 26(2), point (a), the national competent authorities concerned may request
information from promoters of industrial projects, project promoters, marketing
authorisation holders and other actors in the supply and distribution chains of critical
medicinal products, their ▌ active substances or key inputs, including from importers and
manufacturers of medicinal products, active substances or key inputs and relevant
suppliers of these, wholesale distributors, stakeholder representative associations or other
natural or legal persons or legal entities that are authorised or otherwise entitled to supply
medicinal products to the public.
For the purposes of Article 30, the national competent authorities and the Commission may
request information from the market actors referred to in paragraph 1, contracting
authorities and other stakeholders.
For the purposes of Article 11(2), the Agency may request information from project
promoters, marketing authorisation holders, manufacturers of medicinal products and
manufacturers or suppliers of active substances or key inputs.
2. Where information is requested by national competent authorities or the Agency, as
relevant, pursuant to paragraph 1, an actor may indicate that the information requested has
already been provided to the national competent authority concerned or the Agency
pursuant to other relevant Union legal acts. In such cases, the national competent authority
concerned or the Agency shall take due account of the information already provided in so
far as this information has been provided and may be used also for the purposes of this
Regulation.
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3. Where a market actor submits information pursuant to paragraph 1, that actor shall
indicate whether the information provided contains any commercially confidential
information, identify the relevant parts of that information having a commercially
confidential nature and explain why that information is of such nature. The Commission,
the national competent authority or the Agency, as relevant, shall assess the merits of each
confidentiality claim made by the actors and shall protect any information that is
commercially confidential against unjustified disclosure in accordance with Article 29a.
Article 29a
Handling of confidential information
1. Information acquired in the course of implementing this Regulation shall be protected by
the relevant Union and national law.
2. Member States, the Commission and the Agency shall ensure the protection of trade and
business secrets and other commercially confidential information obtained and processed
in application of this Regulation, in accordance with relevant Union and national law.
3. The Commission, the Agency and the national competent authorities, their officials,
employees and other persons working under the supervision of those authorities shall
ensure, in accordance with relevant Union or national law, the confidentiality of
information obtained while carrying out their tasks and activities pursuant to this
Regulation. This obligation also applies to all representatives of Member States, observers,
experts and other participants attending meetings of the CMCG pursuant to Article 25.
4. A Member State may refuse to share information where it concerns the essential interests
of its security and defence.
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Article 30
Evaluation
1. By … [five years from the date of application of this Regulation] and every five years
thereafter, the Commission shall evaluate this Regulation, including its impact on the
security of supply of medicinal products and the use of collaborative procurement and
submit a report on the main findings to the European Parliament, the Council, the European
Economic and Social Committee, and the Committee of the Regions.
2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent
its objectives as established in Article 1 have been achieved. The evaluation shall include an
assessment of the scope, functioning and efficiency of Article 18, as well as of the
coherence of this Regulation with the developments in the field of public procurement.
3. The national authorities and other actors shall, upon request, provide the Commission with
any relevant information they have and that the Commission may need for its assessment
pursuant to paragraphs 1 and 2.
3a. The report referred to in paragraph 1 shall, where appropriate, be accompanied by
legislative proposals.
Article 30a
Committee Procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee
within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall
apply.
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Article 31
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
It shall apply from the date of the first publication in the Official Journal of the Union list of
critical medicinal products established in accordance with Article 137 of Regulation (EU) …/…+.
The requirements in Article 18(1) and (2) shall apply to public procurement procedures launched
after that date.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg,
For the European Parliament For the Council
The President The President
+ OJ: please insert in the text the number of the Regulation in document ST 7105/26
(2023/0131(COD)).
2026-06-30T15:33:26+0000
Guarantee of Integrity and Authenticity
02.07.2026
Datei
PD
Wie sich das GKV-Beitragssatz-
Stabilisierungs-Gesetz (BStabG) auf die
Innovationsfähigkeit der Pharmabranche
und die Arzneimittelversorgung auswirkt
Die zentralen Aspekte auf einen Blick
• Die im BStabG geplanten Sparmaßnahmen zielen hauptsächlich auf den
Patentmarkt, aber auch der Generikamarkt ist betroffen.1
• Rund 85 Prozent dieses patentgeschützten Arzneimittelmarktes entfallen auf
Arzneimittel gegen lebensbedrohliche oder schwere chronische
Erkrankungen: Krebs, schwere Autoimmun- und Entzündungserkrankungen,
Schlaganfall-Prävention und Thrombose sowie Diabetes mit
Folgeerkrankungen.2
• Die GKV-Arzneimittelausgaben lagen 2025 bei 58,49 Mrd. Euro (+5,9 % im
Vergleich zum Vorjahreszeitraum). Mit einem Anstieg der Leistungsausgaben
um 5,9% ist das Wachstum im Vergleich zu anderen Leistungsbereichen
unterdurchschnittlich. Zur Einordnung: die Leistungsausgaben stiegen um 7,9
%, Ausgaben für Krankenhausbehandlungen um 9,6 %, Ausgaben für
ambulant ärztliche Behandlungen um 7,6%.
1BMG, Finanzentwicklung GKV 2025; AOK Arzneimittel-Kompass 2025.
https://www.bundesgesundheitsministerium.de/ministerium/meldungen/finanzentwicklung-gkv-2025
2Eigene Berechnung auf Basis IQVIA-Marktbericht Q4/2025 (GKV-Gesamtmarkt 59,3 Mrd. €) und AOK Arzneimittel-Kompass 2025
(patentgeschützter Markt = 54 % der Kosten). https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-
marktbericht-classic-q4-2025.pdf
https://www.bundesgesundheitsministerium.de/ministerium/meldungen/finanzentwicklung-gkv-2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
• 3Der geplante (dynamische) Herstellerabschlag kann den Zwangsrabatt auf
innovative Arzneimittel bis 2030 auf über 20 Prozent treiben – eine
Verfünffachung der jährlichen Belastung von 1,1 auf 5,5 Mrd. Euro.4
• Die Maßnahmen wirken kumulierend. Dynamischer Herstellerabschlag,
neue Rabattverträge für patentgeschützte Arzneimittel, Preis-Mengen-
Regelungen und das verlängerte Preismoratorium treffen dieselben
Arzneimittel gleichzeitig und übereinander gelagert. Damit gefährdet nicht nur
jede Maßnahme für sich, sondern insbesondere ihr Zusammenwirken Zugang,
Therapievielfalt und Standort.5
• Die Preissenkungen wirken additiv auf bereits verhandelte Preise. Also
Preise, die im Rahmen des AMNOG-Verfahrens bereits auf der Basis von
Nutzenbewertungen gefunden wurden. Aus dieser Basis wurde mit der
Krankenkasse ein Preis verhandelt, der dem Wert des Arzneimittels für
Patienten entspricht.
• Die Pharmaindustrie ist mit einer Investitionsquote von 5,7 Prozent die
investitionsstärkste Industrie Deutschlands. Kurzfristige, kumulierende
Preiseingriffe gefährden langfristig geplante Standortinvestitionen.6
4Pharma Deutschland: Risiken des GKV-BStabG für Arzneimittelversorgung und Innovation.
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-
innovation/
5Pharma Deutschland: Inhalte des GKV-Beitragssatzstabilisierungsgesetzes.
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
6IW Köln, PharmaKompakt 2025.
https://www.iwkoeln.de/fileadmin/user_upload/Studien/Gutachten/Pharma_Standort_D/2025/PharmaKompakt_2025_DE.pdf
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
https://www.iwkoeln.de/fileadmin/user_upload/Studien/Gutachten/Pharma_Standort_D/2025/PharmaKompakt_2025_DE.pdf
Verteilung des GKV-Umsatzes nach
Erkrankungsschwere (2025)
Das GKV-BStabG belastet ausgerechnet den Marktteil am stärksten, der die
Versorgung Schwerstkranker sichert und die forschungs- und investitionsstärkste
Industrie Deutschlands trägt.7
Erkrankungskategorie Beispiel-Wirkstoffklassen (Cluster) GKV-Umsatz
2025* Anteil**
Krebserkrankungen &
Immuntherapien
MAB-Antineoplastika,
Proteinkinasehemmer,
Hormonantagonisten
~ 9,5 – 10,1
Mrd. € ~ 39 %
Schwere Autoimmun-
/Entzündungserkrankungen
Anti-TNF, Interleukin-Inhibitoren,
JAK-Inhibitoren, MS-Mittel
~ 6,8 – 7,0
Mrd. € ~ 28 %
Diabetes mit schweren
Komplikationen
SGLT2-Hemmer, GLP-1-Agonisten,
Insulin-Analoga
~ 5,0 – 5,2
Mrd. € ~ 21 %
Schlaganfall-Prävention &
Thrombose
Direkte Faktor-Xa-Hemmer
(Apixaban, Rivaroxaban, Edoxaban)
~ 2,9 – 3,0
Mrd. € ~ 12 %
Summe vier Cluster
Summe
schwere/lebensbedrohliche
Erkrankungen (vier Cluster)
~ 24,2 – 25,3
Mrd. €
~ 41 – 43
% des
GKV-
Marktes
\.GKV‗Umsatz.868❶.(IQVIA.Apothekenmarkt?.Jan Dez.868❶)¡.\\.Anteil.der.ersten.drei.Spalten.am.umsatzstarken.
Marktsegment.der.vier.Cluster.(∫ .80?8 8❶?9.Mrd¡.₭)·.die.letzte.Zeile.bezieht.den.Anteil.auf.den.GKV‗Gesamtmarkt.(❶❺?9.Mrd¡.
₭)¡.Werte.gerundet·.Schätzung.auf.Basis.der.ATC‗Gruppen.und.Hauptindikationen¡
7Eigene Berechnung auf Basis der ATC-Umsätze 2025 (IQVIA Q4/2025) der vier Versorgungscluster. Der Arzneimittel-Atlas 2025
bestätigt qualitativ, dass es sich „ganz überwiegend um Arzneimittel gegen sehr schwere bis mittelschwere Erkrankungen“ handelt.
https://www.mwv-
berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d209028
29b3955df25e0387fe2f3c1c2b.pdf
https://www.mwv-berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d20902829b3955df25e0387fe2f3c1c2b.pdf
https://www.mwv-berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d20902829b3955df25e0387fe2f3c1c2b.pdf
https://www.mwv-berlin.de/media/6e519139dabd9dfbca62c3f478d646dc35455018/5d37c448e19e26162cefe943c7dffc6d3804501f/e73dff2d20902829b3955df25e0387fe2f3c1c2b.pdf
Die vier Therapie-Cluster (Datenbasis 2025)
Die umsatzstärksten patentgeschützten Präparate ordnen sich vier Versorgungs-
Clustern zu. Für jedes Cluster sind Leit-Wirkstoffklassen, GKV-Umsatz 2025 und
Marktentwicklung dargestellt.
Übersicht: Cluster-Umsätze im GKV-Markt 2025
Therapie-Cluster GKV-Umsatz
2025 (Schätzung)
Anteil
Gesamtmarkt
Wachstum
vs. 2024
Leit-
Wirkstoffklassen
Onkologie &
Immuntherapien 9,5 – 10,1 Mrd. € 16 – 17 % +10 – 12 %
MAB-Antineoplastika,
Proteinkinasehemmer,
Hormonantagonisten
Autoimmun- &
entzündliche
Erkrankungen
6,8 – 7,0 Mrd. € 11,5 – 11,8 % -5 bis -8 %
Anti-TNF, Interleukin-
Inhibitoren, JAK-
Inhibitoren, MS-Mittel
Diabetes &
Stoffwechsel 5,0 – 5,2 Mrd. € 8,5 – 8,8 % +20 – 25 %
SGLT2-Hemmer,
GLP-1-Agonisten,
Insulin-Analoga
Herz-Kreislauf &
Thrombose (B01) 2,9 – 3,0 Mrd. € ~ 5,0 % +0,8 %
(B01F)
Direkte Faktor-Xa-
Hemmer, ARNI,
PCSK9-Inhibitoren
Quelle¿.IQVIA.Pharma‗Marktbericht.Q0―868❶.(Gesamtjahr.868❶?.ATC‗Gruppen)·.ergänzt.um.GAmSi.Bayern.Q7―868❶.und.
Arzneimittel‗Atlas.868❶¡.Schätzungen·.Überschneidungen.(SGLT8‗Hemmer.Diabetes―Herz‗Kreislauf).im.Text.gekennzeichnet¡.
Vier.Cluster.gesamt.∫ .80?8 8❶?9.Mrd¡.₭.(∫ .07 09.↘ .des.GKV‗Marktes)¡8
8IQVIA Pharma-Marktbericht Q4/2025; GAmSi Bayern KV71 Q1/2025; IGES Arzneimittel-Atlas 2025. https://www.iqvia.com/-
/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Cluster Onkologie & Immuntherapien
GKV-Umsatz 2025 ≈ 9,5 – 10,1 Mrd. € (L01G 4.327 Mio. € +5,8 %; L01H 3.298 Mio. €
+14,0 %; L02B 1.502 Mio. €)
Versorgte Indikationen
Diverse Krebserkrankungen: nicht-kleinzelliges Lungenkarzinom,
Melanom, multiples Myelom, chronische lymphatische Leukämie,
Mammakarzinom, Prostatakarzinom u. v. m.
Leitpräparate
(Wirkstoffklassen)
PD-1/PD-L1-Inhibitoren (Checkpoint-Inhibition), Proteinkinasehemmer
(CDK-, BTK-Inhibitoren), CD38-Antikörper, EGFR-Inhibitoren,
zytostatische Hormonantagonisten
Investitionsschwerpunkt
Plattformtechnologien (Antikörper, Checkpoint-Inhibition),
biopharmazeutische Produktion, Kombinations- und
Sequenztherapien; höchste Wachstumsrate aller Cluster
(Proteinkinasehemmer L01H +14,0 % p. a.).
Gefährdung durch das GKV-BStabG
• Ein onkologisches bereits preisverhandeltes Präparat kann gleichzeitig vom
(dynamischen) Herstellerabschlag, vom Rabattvertrag für patentgeschützte
Arzneimittel (PD-1/PD-L1- bzw. PARP-Inhibitoren als Pilotgruppen) und
Preis-Mengen-Vereinbarungen getroffen werden.
• Rabattverträge auf PD-1/PD-L1- und PARP-Inhibitoren zwingen
therapeutisch nicht beliebig austauschbare Wirkstoffe in einen
Preiswettbewerb.
• Die zusätzlichen Abschläge machen Markteinführungen neuer Indikationen
unkalkulierbar.
Quelle¿.IQVIA Q4/2025; GAmSi Bayern Q1/2025; Der Arzneimittelbrief 2026
https://der-arzneimittelbrief.com/artikel/2026/keytruda-teuerstes-krebsmedikament-moegliche-einsparpotenziale-und-wie-krankenkassen-unnoetig-finanziell-belastet-werden
Cluster Autoimmun- & entzündliche Erkrankungen
GKV-Umsatz 2025 ≈ 6,8 – 7,0 Mrd. € (L04C 2.404 Mio. € -24,1 %; L04B 2.242 Mio. € -4,1
%; N07A MS 1.681 Mio. €)
Versorgte Indikationen
Rheumatoide Arthritis, Psoriasis/Psoriasisarthritis, Morbus Crohn,
Colitis ulcerosa, atopische Dermatitis, Multiple Sklerose, Spondylitis
ankylosans
Leitpräparate
(Wirkstoffklassen)
Anti-TNF-Inhibitoren (Adalimumab), Interleukin-Inhibitoren
(Ustekinumab, Risankizumab, Secukinumab, Dupilumab), JAK-
Inhibitoren (Upadacitinib), MS-Mittel
Investitionsschwerpunkt
Biologika und niedermolekulare Immunmodulatoren (JAK),
Indikationserweiterungen über mehrere chronische Erkrankungen;
bereits intensiver Biosimilar-Wettbewerb (L04C -24,1 % Umsatz bei
nur -4,9 % Absatz, getrieben durch das Ustekinumab-Biosimilar).
Gefährdung durch das GKV-BStabG
• Das Cluster steht bereits unter starkem Biosimilar-Preiswettbewerb
(Umsatz L04C -24,1 % zzgl. hoher vertraulicher Rabatte). Der (dynamische)
Herstellerabschlag legt sich zusätzlich auf die verbleibenden
patentgeschützten Wirkstoffe – mit dem Risiko, dass einzelne Indikationen
unwirtschaftlich werden.
• JAK-Inhibitoren stehen auf der Pilotliste für Rabattverträge auf
patentgeschützte Arzneimittel. Sie werden damit doppelt erfasst: durch den
dynamischen Abschlag und durch einen Substitutionszwang nach
Rabattvertrag – trotz unterschiedlicher Sicherheitsprofile und Zulassungen.
Quelle¿.IQVIA Q4/2025 (L04C 2.404 Mio. €, L04B 2.242 Mio. €); GAmSi Bayern Q1/2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Cluster Diabetes & Stoffwechsel
GKV-Umsatz 2025 ≈ 5,0 – 5,2 Mrd. € (A10P SGLT2 2.013 Mio. € +15,1 %; A10S GLP-1
1.261 Mio. € +56,0 %; A10C Insulin 1.186 Mio. €)
Versorgte Indikationen Typ-2-Diabetes, Herzinsuffizienz (HFrEF/HFpEF), chronische
Niereninsuffizienz; kardiometabolische Folgeerkrankungen
Leitpräparate
(Wirkstoffklassen)
SGLT2-Hemmer (Empagliflozin, Dapagliflozin), GLP-1-Agonisten
(Semaglutid, Tirzepatid), Insulin-Analoga
Investitionsschwerpunkt
Indikationsausweitung kardiometabolischer Wirkstoffe (Herz, Niere);
stärkstes Mengen- und Umsatzwachstum im gesamten GKV-Markt
(GLP-1-Agonisten +56 % Umsatz, +24,2 % Absatz), hohe Public-
Health-Relevanz.
Gefährdung durch das GKV-BStabG
• Der (dynamische) Herstellerabschlag koppelt die Rabatthöhe an das
Ausgabenwachstum des Patentmarktes. Gerade die wachstumsstärksten
Cluster – SGLT2-Hemmer (+15,1 %) und GLP-1-Agonisten (+56 %) –
treiben damit ihren eigenen Zwangsrabatt nach oben und kumulieren so
die Belastung über die Jahre.
• Die Preis-Mengen-Regelung als gesetzliche Auffanglösung (ohne
Schiedsstellenbefassung) legt sich zusätzlich auf volumenstarke
Stoffwechseltherapien und erhöht die Belastung ein weiteres Mal.
Quelle¿.IQVIA Q4/2025 (A10P, A10S, A10C); GAmSi Bayern Q1/2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Cluster Herz-Kreislauf & Thrombose
GKV-Umsatz 2025 ≈ 2,9 – 3,0 Mrd. € (B01F Direkte Faktor-Xa-Hemmer 2.705 Mio. € +0,8
%); mit Lipidsenkern/PCSK9 ≈ 4,4 – 5,0 Mrd. €
Versorgte Indikationen
Schlaganfall-Prävention bei Vorhofflimmern, Therapie und Prophylaxe
von Venenthrombose und Lungenembolie, Herzinsuffizienz,
Sekundärprävention kardiovaskulärer Ereignisse
Leitpräparate
(Wirkstoffklassen)
Direkte Faktor-Xa-Hemmer (Apixaban, Rivaroxaban, Edoxaban), ARNI
(Sacubitril/Valsartan), PCSK9-Inhibitoren
Investitionsschwerpunkt
Großvolumige Versorgung mit hohem Public-Health-Nutzen
(Schlaganfall-Vermeidung); Lebenszyklus-Management und
Folgeindikationen.
Gefährdung durch das GKV-BStabG
• PCSK9-Inhibitoren sind eine der fünf Pilot-Wirkstoffgruppen für
Rabattverträge – ein Eingriff in die Sekundärprävention. Gleichzeitig greift
auf patentgeschützte Wirkstoffe des Clusters der (dynamische)
Herstellerabschlag; beide Maßnahmen wirken übereinander.
• Faktor-Xa-Hemmer (orale Antikoagulanzien, B01F: 2.705 Mio. € 2025)
zählen zu den umsatzstärksten Präparaten überhaupt und sind
lebensnotwendig für die Schlaganfall-Prävention. Diese pauschalen,
kumulierenden Abschläge gefährden die wirtschaftliche Versorgung
großer Patientengruppen.
Quelle¿.IQVIA Q4/2025 (B01F 2.704,5 Mio. €); GAmSi Bayern Q1/2025
https://www.iqvia.com/-/media/iqvia/pdfs/germany/library/publications/iqvia-pharma-marktbericht-classic-q4-2025.pdf
Die pharmarelevanten Maßnahmen des GKV-BStabG
(Dynamischer) Herstellerabschlag (§ 130a Abs. 1b SGB V-E)
Was
Der bestehende Herstellerabschlag von 7 % auf patentgeschützte
Arzneimittel wird um eine dynamische Komponente ergänzt, die an die
Ausgabenentwicklung im Patentmarkt gekoppelt ist. Alternativ ist auch ein
fixer Gesamtrabatt von 15,5% in der Diskussion
Zeitplan
Jan.–Jun. 2027: statisch +3,5 Prozentpunkte (= 10,5 %). Ab Juli 2027:
jährlich dynamisch berechneter Zusatzabschlag, Höhe abhängig von
Ausgaben- und Einnahmenentwicklung.
Finanzieller
Umfang
1,1 Mrd. € (2027) bis 5,5 Mrd. € (2030) – eine Verfünffachung; Simulationen
zeigen einen Gesamtabschlag von über 20 % bis 2030.
Ausnahmen
Festbetragsarzneimittel, Generika, Biosimilars, Impfstoffe, patentfreie
versorgungskritische Arzneimittel nach §52b Abs. 3c AMG, patentfreie
Kinderarzneimittel nach §35 Abs. 5a SGB V, vom Preismoratorium befreite
Arzneimittel, Reserveantibiotika, Wirkstoffe mit klinischen Studien und
Produktion in Deutschland.
Auswirkungen
• Ein (dynamischer, jährlich neu festgesetzter) Zwangsrabatt entzieht
Investitions- und Standortentscheidungen die Kalkulations- und
Planungsgrundlage.
• Jeder zusätzliche Euro Rabatterhöhung schadet der Volkswirtschaft um bis
zu 3,80 Euro.9
Quellen¿.Pharma.Deutschland.―.vfa‗Factsheet·.BMG‗Referentenentwurf¡10
9VCI, Pressemitteilung zum GKV-Sparpaket, April 2026. https://www.vci.de/presse/pressemitteilungen/gkv-sparpaket-der-
bundesregierung.jsp
10Pharma Deutschland: Risiken des GKV-BStabG für Arzneimittelversorgung und Innovation.
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-
innovation/
https://www.vci.de/presse/pressemitteilungen/gkv-sparpaket-der-bundesregierung.jsp
https://www.vci.de/presse/pressemitteilungen/gkv-sparpaket-der-bundesregierung.jsp
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
https://www.pharmadeutschland.de/themen/gkv-beitragssatzstabilisierungsgesetz-risiken-fuer-arzneimittelversorgung-und-innovation/
Rabattverträge für patentgeschützte Arzneimittel
(§ 130e SGB V-E, neu)
Was
Krankenkassen dürfen erstmals Rabattverträge für patentgeschützte
Arzneimittel mit therapeutisch vergleichbarer Wirkung abschließen
(Clusterausschreibungen). Vertragsärzte müssen rabattierte Arzneimittel
verordnen. Ausnahmen sind unter hohem bürokratischem Aufwand zu
begründen..
Pilotphase
Vorerst befristet bis 31.12.2030, zunächst fünf Wirkstoffgruppen: JAK-
Inhibitoren, CGRP-Antagonisten, PARP-Inhibitoren, PCSK9-Inhibitoren, PD-
1/PD-L1-Inhibitoren.
Bericht über die Auswirkungen durch den GKV SV an das BMG.
Cluster-
Betroffenheit
Direkter Eingriff in Onkologie (PD-1/PD-L1, PARP), Herz-Kreislauf (PCSK9),
Autoimmun (JAK) und Neurologie (CGRP).
Auswirkungen
• Innovative, oft nicht gleichwertige Wirkstoffe werden nach ihrer
Nutzenbewertung im AMNOG in einen reinen Preiswettbewerb gezwungen.
Das Ergebnis des AMNOG Verfahrens wird damit gänzlich entwertet. Das
RisikoDas Risiko für die Versorgung sind Marktrücknahmen und eine
eingeschränkte Therapiewahl für Patientinnen und Patienten. Die
Maßnahmen führen zu einer Verschlechterung der Versorgung für bestimmte
Therapiegebiete
• Rabattverträge waren bislang Generika vorbehalten. Ihre Ausweitung auf
den Patentmarkt unterläuft die bereits verhandelten AMNOG-
Erstattungsbeträge und addiert sich auf den dynamischen
Herstellerabschlag derselben Wirkstoffe.
Quellen¿.Pharma.Deutschland¿.Inhalte.des.GKV‗BStabG¡11
11Pharma Deutschland: Inhalte des GKV-Beitragssatzstabilisierungsgesetzes.
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
Preis-Mengen-Regelung
Was Die im Rahmen der 130b SGB V zu verhandelnde Preis-Mengen Regelung
wird gesetzlich festgeschrieben.
Finanzieller
Umfang
Je 100 Mio.€ Umsatz plus 1% Preisabschlag. Das ist eine Verzehnfachung
der bisherigen Preis-Mengen-Regel die im Rahmen des GKV-FinStabG in
2023 geschaffen wurde
Cluster-
Betroffenheit
Alle Arzneimittel mit Erstattungsbetrag nach §130b SGB V, Rückwirkung
durch Sonderkündigungsrecht
Auswirkungen
• Eine starrer Preis-Mengen-Algorithmus nimmt der Kassen und der Industrie
Verhandlungsfreiheit. Es kann nicht mehr der Einzelfall berücksichtigt
werden
• Mengen steigen durch mehr Nachfrage nach einem Arzneimittel. Gründe
dafür sind Demographie (mehr Arzneimittelverbrauch) oder der hohe Nutzen
für den Patient. Diese Regelung bestrafft also gerade Arzneimittel, die für
den Patienten einen hohen Wert bieten
Kumulative Wirkung der Maßnahmen
Herstellerabschlag, Rabattverträge für patentgeschützte Arzneimittel und die Preis-
Mengen greifen gleichzeitig und übereinander in die Innovationscluster Onkologie,
Autoimmun, Diabetes und Herz-Kreislauf ein. Diese kumulierenden Effekte werden
sich unmittelbar auf die Therapievielfalt, die Markteinführungen und die langfristige
Produktionsinvestitionen am Standort Deutschland auswirken und sich bei der
Arzneimittelversorgung, der Wirtschaftskraft der Pharmazeutischen Industrie und
damit der wirtschaftlichen Entwicklung Deutschlands negativ bemerkbar machen.
Die kombinierte Netto-Belastung der Pharmaindustrie aus dynamischem
Herstellerabschlag, Rabattverträgen und Preis-Mengen-Regelung beziffert das BMG
für 2030 auf 5,75 Mrd. Euro – knapp 19 % der Gesamteinsparungen über alle
Sektoren, obwohl der Arzneimittelmarkt nur 12% der Leistungsausgaben ausmacht.
Instrument Aktuell Geplant 2027
Allg. Herstellerabschlag 7 % 10,5 % (dynamisch)
Alternativ fixer
Herstellerabschlag 7% 15,5%
Rabattverträge Patent-AM nicht möglich
Pilot für 5 Wirkstoffgruppen,
Annahme 30% Rabatt
(Techniker Krankenkasse in
Pharma Dialog Äußerungen
von 50%)
Preis-Mengen-Vereinbarung 0,1% pro 100
Mio € 1% pro 100 Mio €
Mehrfachbelastung je Cluster
Die folgende Matrix macht sichtbar, dass die meisten Cluster nicht von einer, sondern
von mehreren Maßnahmen gleichzeitig getroffen werden. Genau diese Überlagerung –
nicht die einzelne Maßnahme – ist die eigentliche Gefahr für Innovation und Versorgung.
Cluster AMNOG
Prozess
(Dyn.)
Herstellerabschlag
Rabattvertrag
(Pilot)
Preis-
Mengen-
Regelung
Belastungsstufen
Onkologie &
Immuntherapien ja ja ja (PD-1/PD-
L1, PARP) ja 4-fach
Autoimmun &
Entzündung ja ja ja (JAK) – 3-fach
Herz-Kreislauf &
Thrombose ja ja ja (PCSK9) – 3-fach
Diabetes &
Stoffwechsel ja ja
(selbstverstärkend) – – 2-fach
Lesehilfe¿.«Belastungsstufen».zählt?.wie.viele.der.kritisierten.Instrumente.einen.Cluster.direkt.erfassen¡.Das.Onkologie‗
Cluster.trägt.mit.vier.sich.überlagernden.Maßnahmen.die.höchste.kumulative.Belastung·.im.Diabetes‗Cluster.verstärkt.der.
dynamische.Abschlag.durch.die.Wachstumskopplung.sich.selbst¡12
12Eigene Darstellung auf Basis Pharma Deutschland: Inhalte des GKV-BStabG; § 130a/§ 130e SGB V-E.
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
https://www.pharmadeutschland.de/newsroom/news/inhalte-des-gkv-beitragsstabilisierungsgesetz/
Zwei exemplarische Beispiele wie sich die
Kumulation finanziell auswirken wird am Beispiel des
statischen Herstellerabschlages
Ein Onkologikum oder ein anderes patentgeschütztes Präparat kann 2027 ff. zusätzlich
zum bereits verhandelten AMNOG-Erstattungsbetrag und zum Preismoratorium zur
selben Zeit dem (dynamischen) Herstellerabschlag, einem Rabattvertrag (PD-1/PD-L1
oder PARP) und Preis-Mengenvereinbarungen unterliegen.
Jede Maßnahme aus dem GKV-Beitragssatz-Stabilisierungs-Gesetz mag für sich
begrenzt erscheinen. In der Überlagerung der Maßnahmen entsteht eine Belastung, die
einzelne Indikationen oder Wirkstoffe unwirtschaftlich machen und zu
Marktrücknahmen führen kann.
Instrument Präparat xy 100 Mio €
Umsatz
Präparat xy 500 Mio €
Umsatz
AMNOG Verfahren z.B.
Beträchtlicher Zusatznutzen -30%
verhandelter Erstattungsbetrag,
(Mittelwert AMNOG
Verhandlungen,
Herstellerabschlag abgelöst)
-30% bereits erfolgt -30% bereits erfolgt
Neu:
Allg. Herstellerabschlag -15,5% 15,5%
Rabattverträge Patent-AM
(geschätzt anhand von
Kassenerwartungen)
-30% -30%
Preis-Mengen-Vereinbarung 100 Mio € x 1% = -1% 500 Mio € x 1% = -5%
Ergebnis in Prozent (Summe
Maßnahmen BStabG) -46,5% - 50,5%
Ergebnis in € (Summe
Maßnahmen BStabG) 53,5 Mio € nach Rabatten 247,5 Mio € nach Rabatten
Diese Beispiele zeigen sehr eindrücklich was für extreme Auswirkungen die Kumulation
der Rabatte auf die Umsätze der Industrie hat. Dieses wird noch verschärft durch
internationale Preisreferenzierung, die die Auswirkungen auf den internationalen
Märkten für die Industrie ca. mit dem Faktor 4 erhöht.
Jedes Unternehmen muss sich die betriebswirtschaftliche Frage stellen, ob es
ökonomisch sinnvoll ist die Arzneimittel in Deutschland weiter zu vertreiben. Das ist
keine Drohung, sondern betriebswirtschaftliche Realität, wie in jeder anderen Branche
auch.
Einordnung und Methodik
• Pharma Deutschland hat die Wirkung des GKV-
Beitragssatzstabilisierungsgesetzes (GKV-BStabG) auf die forschende
Pharmaindustrie in Deutschland analysiert. Als Grundgesamtheit dienen die
umsatzstärksten patentgeschützten Präparate bzw. ihre Hersteller im
deutschen GKV-Markt. Die Darstellung der Auswirkungen erfolgt nach vier
Therapie-Clustern, um die gesellschaftliche Bedeutung der betroffenen
Versorgung in den Vordergrund zu stellen.
• Der GKV-Arzneimittelmarkt erreichte 2025 ein Volumen von rund 58,49 Mrd.
Euro (+5,9 % gegenüber 2024);13. Auf patentgeschützte Arzneimittel entfielen
davon rund 54 Prozent der Kosten. Genau dieser hochinnovative Patentmarkt
steht im Zentrum der geplanten Sparmaßnahmen.
• Alle quantitativen Aussagen sind über Fußnoten mit den jeweiligen Primär- bzw.
Verbandsquellen belegt. Die Marktwerte 2025 stammen aus dem IQVIA
Pharma-Marktbericht Q4/2025 (Gesamtjahr 2025, Bundesdaten) und dem BMG
(KV45). Cluster-Umsätze sind Schätzungen auf Basis der ATC-Gruppen des
IQVIA-Berichts 2025 und der GAmSi-Quartalsdaten (Bayern KV71 Q1/2025)
sowie der Hauptindikationen; Überschneidungen zwischen Clustern (z. B.
SGLT2-Hemmer in Diabetes und Herzinsuffizienz) sind möglich und im Text
gekennzeichnet.
Quellen und Hinweise:
• Die Datenbasis bilden der GKV-GAmSi-Quartalsbericht 2025, die IQVIA
Pharma-Marktberichte Q2–Q4/2025 mit Bundesdaten für das Gesamtjahr 2025,
der IGES Arzneimittel-Atlas 2025, der AOK Arzneimittel-Kompass 2025, das
arznei-telegramm 8/2025 sowie ergänzende Verbands- und
Ministeriumsquellen.
• Zentrale Primärquellen sind insbesondere IQVIA Pharma-Marktbericht Q2–
Q4/2025, BMG Finanzentwicklung GKV 2025 (KV45), GKV-GAmSi Bayern
KV71 Q1/2025, IGES Arzneimittel-Atlas 2025, AOK Arzneimittel-Kompass
2025, arznei-telegramm 8/2025, IW Köln PharmaKompakt 2025, vfa AMNOG-
Daten und der BMG-Referentenentwurf zum GKV-BStabG.
• Die Cluster-Umsätze sind Schätzungen auf Basis der ATC-Gruppen und der
Hauptindikationen; Überschneidungen zwischen Clustern, etwa bei SGLT2-
Hemmern in Diabetes und Herzinsuffizienz, sind möglich und im Text
gekennzeichnet.
• Vollständige URLs finden sich in den Fußnoten.
Abkürzungs- und Begriffsverzeichnis
Gesetze und Paragrafen
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
AMNOG Arzneimittelmarkt-
Neuordnungsgesetz
Seit 2011 geltendes Gesetz. Regelt, dass für
jedes neue Arzneimittel der Zusatznutzen
bewertet und daraufhin ein Erstattungspreis
mit den Kassen verhandelt wird.
GKV-BStabG GKV-
Beitragssatzstabilisierungsgesetz
Das im Fact-Sheet analysierte „Spargesetz
2025/26“. Soll die Beitragssätze der
gesetzlichen Krankenversicherung
stabilisieren – u. a. durch neue Abschläge auf
patentgeschützte Arzneimittel.
SGB V Fünftes Buch Sozialgesetzbuch Das zentrale Gesetzbuch zur gesetzlichen
Krankenversicherung in Deutschland.
SGB V-E Sozialgesetzbuch V –
Entwurfsfassung
Der Zusatz „-E“ kennzeichnet eine geplante,
noch nicht in Kraft getretene Fassung
(Gesetzentwurf).
§ 130a SGB V Paragraf zum Herstellerabschlag
Rechtsgrundlage für den (auch dynamischen)
Zwangsrabatt, den Hersteller den Kassen
gewähren müssen.
§ 130b SGB V Paragraf zur
Erstattungsbetragsverhandlung
Regelt die AMNOG-Preisverhandlung; Abs. 3
enthielt die sogenannten „Leitplanken“.
§ 130e SGB V Paragraf zu Kombinations- und
Patent-Rabatten
Rechtsgrundlage für den
Kombinationsabschlag und – neu geplant – für
Rabattverträge auf patentgeschützte
Arzneimittel.
BVerfG Bundesverfassungsgericht Höchstes deutsches Gericht; prüfte 2025 die
Verhältnismäßigkeit des Preismoratoriums.
G-BA Gemeinsamer Bundesausschuss
Oberstes Beschlussgremium der
Selbstverwaltung im Gesundheitswesen;
benennt u. a. die von Abschlägen betroffenen
Wirkstoff-Kombinationen.
Institutionen, Verbände und Datenquellen
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
AOK Allgemeine Ortskrankenkasse Größte gesetzliche Krankenkassengruppe;
gibt den „Arzneimittel-Kompass“ heraus.
arznei-telegramm Unabhängiger Arzneimittel-
Informationsdienst
Herstellerunabhängige Fachpublikation zur
Bewertung von Arzneimitteln.
BMG Bundesministerium für Gesundheit Zuständiges Ministerium; veröffentlicht u. a.
die GKV-Finanzentwicklung (Statistik „KV45“).
BPI Bundesverband der
Pharmazeutischen Industrie
Branchenverband der Pharmaindustrie in
Deutschland.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
CDMO Contract Development and
Manufacturing Organization
Auftragsentwickler und -hersteller;
Dienstleister, die Arzneimittel für andere
Firmen produzieren.
GAmSi GKV-Arzneimittel-
Schnellinformation
Amtliche, zeitnahe Statistik über
Arzneimittelverordnungen zu Lasten der
gesetzlichen Krankenkassen.
GKV Gesetzliche Krankenversicherung
Das solidarisch finanzierte
Pflichtversicherungssystem, in dem rund 90 %
der Bevölkerung versichert sind.
GKV-Spitzenverband Spitzenverband Bund der
Krankenkassen
Zentrale Interessenvertretung aller
gesetzlichen Kranken- und Pflegekassen;
verhandelt u. a. die Erstattungsbeträge.
IGES IGES Institut
Forschungs- und Beratungsinstitut im
Gesundheitswesen; erstellt den „Arzneimittel-
Atlas“.
IQVIA IQVIA
(Marktforschungsunternehmen)
Führender Anbieter von Markt- und
Verordnungsdaten im Gesundheitswesen;
Quelle des „Pharma-Marktberichts“.
IW Köln Institut der deutschen Wirtschaft
Köln
Wirtschaftsforschungsinstitut; erstellt u. a. die
Studie „PharmaKompakt“.
KV45 / KV71 Amtliche GKV-Finanz- bzw.
Statistikvordrucke
Standardisierte Meldeformulare der Kassen;
„KV45“ = GKV-Finanzergebnisse, „KV71“ =
regionale Verordnungsstatistik (hier Bayern).
MWV Medizinisch Wissenschaftliche
Verlagsgesellschaft
Verlag, in dem u. a. der Arzneimittel-Atlas
erscheint.
VCI Verband der Chemischen Industrie Branchenverband der Chemie- und
Pharmaindustrie in Deutschland.
vfa Verband forschender
Arzneimittelhersteller
Interessenverband der forschenden
Pharmaunternehmen in Deutschland.
Sparmaßnahmen und Begriffe der Preisregulierung
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
AMNOG-Leitplanken Preisobergrenzen im AMNOG-
Verfahren
Gesetzliche Deckelung des verhandelbaren
Preises je nach Zusatznutzen. Werden durch
das GKV-BStabG abgeschafft (Erfolg aus
Branchensicht).
Dynamischer
Herstellerabschlag
An das Ausgabenwachstum
gekoppelter Zwangsrabatt
Pflichtrabatt der Hersteller auf
patentgeschützte Arzneimittel, der mit
steigenden Patentmarkt-Ausgaben
automatisch mitwächst – Kern der Kritik im
Fact-Sheet.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
Erstattungsbetrag Verhandelter Preis in der GKV
Der zwischen Hersteller und Kassen
ausgehandelte Preis, den die GKV für ein
neues Arzneimittel erstattet.
Festbetrag Erstattungshöchstgrenze für
Arzneimittelgruppen
Fester Höchstbetrag, den die Kasse für
vergleichbare Wirkstoffe zahlt; darüber zahlt
der Patient die Differenz.
Herstellerabschlag Gesetzlicher Pflichtrabatt der
Hersteller
Fester (bislang 7 %) Zwangsrabatt auf den
Herstellerabgabepreis patentgeschützter
Arzneimittel.
Kombinationsabschlag Rabatt auf Kombinationstherapien
(§ 130e)
Seit Oktober 2024 20 % Abschlag auf
patentgeschützte Arzneimittel, die in vom G-
BA benannten Kombinationen eingesetzt
werden.
Nutzenbewertung Bewertung des Zusatznutzens
(AMNOG)
Prüfung, ob ein neues Arzneimittel gegenüber
der bisherigen Standardtherapie einen
belegten Zusatznutzen bietet.
Preismoratorium Einfrieren der Herstellerpreise
Seit 2010 sind die Herstellerpreise auf dem
Stand von August 2009 eingefroren;
Verlängerung bis 2030 geplant.
Preis-Mengen-
Regelung
Automatische Preissenkung bei
hohen Absatzmengen
Mechanismus, der bei stark steigenden
Verordnungsmengen den Preis senkt – als
gesetzliche Auffanglösung vorgesehen.
Rabattverträge Exklusive Preisvereinbarungen
einzelner Kassen
Bisher nur bei Generika üblich; sollen künftig
(Pilot) auch für patentgeschützte Arzneimittel
gelten, mit Substitutionspflicht für Ärzte.
Substitution Austausch durch ein anderes
Präparat
Ersetzen des verordneten Arzneimittels durch
ein rabattiertes, therapeutisch vergleichbares
Präparat.
Tagesdosen (DDD) Definierte Tagesdosis (Defined
Daily Dose)
Statistische Maßeinheit für die verordnete
Arzneimittelmenge – erlaubt
Mengenvergleiche unabhängig vom Preis.
Zwangsrabatt Gesetzlich vorgeschriebener
Pflichtrabatt
Umgangssprachlich für gesetzlich verordnete
Abschläge (z. B. Herstellerabschlag), die
Hersteller ohne Verhandlung gewähren
müssen.
ATC-Codes der Wirkstoffgruppen
Das ATC-System (Anatomisch-Therapeutisch-Chemische Klassifikation) ist das
amtliche, weltweit einheitliche Ordnungsschema der WHO für Arzneimittelwirkstoffe.
Jeder Code steht für eine bestimmte Wirkstoffgruppe. Im Fact-Sheet dienen die Codes
dazu, Umsätze markenneutral einzelnen Cluster-Bereichen zuzuordnen.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
A10C Insuline und Insulin-Analoga Blutzuckersenkende Hormonpräparate zur
Diabetes-Behandlung.
A10P SGLT2-Hemmer
Moderne orale Diabetes-Medikamente, die
Zucker über den Urin ausscheiden; auch bei
Herz- und Nierenschwäche wirksam.
A10S GLP-1-Rezeptor-Agonisten
Injizierbare Diabetes- und Adipositas-
Wirkstoffe; wachstumsstärkste Gruppe im
Markt (z. B. Semaglutid).
B01 Antithrombotische Mittel Übergeordnete Gruppe der
Blutgerinnungshemmer.
B01F Direkte Faktor-Xa-Hemmer
Moderne orale Gerinnungshemmer zur
Schlaganfall- und Thrombosevorbeugung (z.
B. Apixaban, Rivaroxaban).
L01G Monoklonale Antikörper
(Antineoplastika) Gezielt wirkende Krebs-Antikörpertherapien.
L01H Proteinkinasehemmer
Zielgerichtete Krebsmedikamente, die
tumorfördernde Enzyme blockieren;
wachstumsstärkste Onkologie-Gruppe.
L02B Hormonantagonisten
Krebstherapien, die hormonabhängiges
Tumorwachstum bremsen (z. B. bei Prostata-
oder Brustkrebs).
L04B / L04C Immunsuppressiva /
Immunmodulatoren
Wirkstoffe gegen überschießende Immun- und
Entzündungsreaktionen (z. B. bei Rheuma,
Psoriasis).
N07A Mittel gegen Erkrankungen des
Nervensystems
Im Fact-Sheet konkret die Wirkstoffe gegen
Multiple Sklerose (MS).
Wirkstoffklassen und medizinische Fachbegriffe
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
Anti-TNF TNF-alpha-Inhibitoren
Biologika, die den Entzündungsbotenstoff
TNF-alpha blockieren (z. B. bei Rheuma,
Morbus Crohn).
ARNI Angiotensin-Rezeptor-Neprilysin-
Inhibitor
Kombinationswirkstoff zur Behandlung der
Herzschwäche (Sacubitril/Valsartan).
Biologika Biotechnologisch hergestellte
Arzneimittel
Aus lebenden Zellen gewonnene, komplexe
Wirkstoffe (z. B. Antikörper) – häufig bei Krebs
und Autoimmunerkrankungen.
BTK-Inhibitoren Bruton-Tyrosinkinase-Inhibitoren Zielgerichtete Wirkstoffe gegen bestimmte
Blutkrebsarten.
CD38-Antikörper Antikörper gegen das
Oberflächenmerkmal CD38
Krebstherapie, v. a. beim multiplen Myelom
(Knochenmarkkrebs).
CDK-Inhibitoren Cyclin-abhängige-Kinase-
Inhibitoren
Zielgerichtete Wirkstoffe, u. a. beim
Brustkrebs.
CGRP-Antagonisten Calcitonin-Gene-Related-Peptide-
Antagonisten
Moderne Migräne-Wirkstoffe; eine der fünf
Pilotgruppen für Rabattverträge.
Checkpoint-Inhibition Immun-Checkpoint-Hemmung Krebs-Immuntherapie, die die körpereigene
Immunabwehr gegen Tumorzellen „entfesselt“.
EGFR-Inhibitoren Epidermal-Growth-Factor-
Receptor-Inhibitoren
Zielgerichtete Krebstherapie, u. a. bei
Lungenkrebs.
Faktor-Xa-Hemmer Direkte orale Antikoagulanzien Blutgerinnungshemmer zur Schlaganfall- und
Thrombosevorbeugung (siehe ATC B01F).
GLP-1-Agonisten GLP-1-Rezeptor-Agonisten Diabetes- und Adipositas-Wirkstoffe (z. B.
Semaglutid, Tirzepatid); siehe ATC A10S.
HFrEF / HFpEF Herzinsuffizienz mit reduzierter /
erhaltener Pumpfunktion
Zwei medizinische Formen der
Herzschwäche.
Interleukin-Inhibitoren Hemmstoffe von Interleukinen
Biologika, die entzündungsfördernde
Botenstoffe (Interleukine) blockieren (z. B. bei
Psoriasis).
JAK-Inhibitoren Januskinase-Inhibitoren
Niedermolekulare (Tabletten-)Wirkstoffe gegen
Autoimmunerkrankungen; eine der fünf
Rabattvertrags-Pilotgruppen.
MAB Monoklonale Antikörper
Im Labor hergestellte, hochspezifische
Antikörper (Wortendung „-mab“, z. B. bei
Krebs).
MS Multiple Sklerose Chronisch-entzündliche Erkrankung des
zentralen Nervensystems.
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
PARP-Inhibitoren Poly-ADP-Ribose-Polymerase-
Inhibitoren
Zielgerichtete Krebstherapie (u. a. Eierstock-,
Brustkrebs); eine der fünf Rabattvertrags-
Pilotgruppen.
PCSK9-Inhibitoren PCSK9-Hemmer
Cholesterinsenker zur Vorbeugung von Herz-
Kreislauf-Ereignissen; eine der fünf
Rabattvertrags-Pilotgruppen.
PD-1 / PD-L1-
Inhibitoren
Programmed-Cell-Death-(Ligand)-
Inhibitoren
Zentrale Krebs-Immuntherapien (Checkpoint-
Inhibitoren); eine der fünf Rabattvertrags-
Pilotgruppen.
Proteinkinasehemmer Kinase-Inhibitoren
Zielgerichtete Krebsmedikamente, die
tumorfördernde Enzyme blockieren (siehe
ATC L01H).
SGLT2-Hemmer Natrium-Glucose-Cotransporter-2-
Hemmer
Diabetes-Wirkstoffe mit Zusatznutzen bei
Herz- und Nierenschwäche (siehe ATC A10P).
Einheiten und sonstige Abkürzungen
Abkürzung / Begriff Bedeutung / Auflösung Kurze Erläuterung
DDD Defined Daily Dose (definierte
Tagesdosis)
Statistische Vergleichseinheit für verordnete
Arzneimittelmengen.
F&E Forschung und Entwicklung Ausgaben für die Erforschung und
Entwicklung neuer Arzneimittel.
Mrd. € Milliarden Euro
Mio. € Millionen Euro
p. a. per annum (pro Jahr)
Q1–Q4 Quartale 1 bis 4 eines Jahres
Verteilung des GKV-Umsatzes nach Erkrankungsschwere (2025)
Das GKV-BStabG belastet ausgerechnet den Marktteil am stärksten, der die Versorgung Schwerstkranker sichert und die forschungs- und investitionsstärkste Industrie Deutschlands trägt.6F
Die vier Therapie-Cluster (Datenbasis 2025)
Übersicht: Cluster-Umsätze im GKV-Markt 2025
Cluster Onkologie & Immuntherapien
Cluster Autoimmun- & entzündliche Erkrankungen
Cluster Diabetes & Stoffwechsel
Cluster Herz-Kreislauf & Thrombose
Die pharmarelevanten Maßnahmen des GKV-BStabG
(Dynamischer) Herstellerabschlag (§ 130a Abs. 1b SGB V-E)
Rabattverträge für patentgeschützte Arzneimittel
(§ 130e SGB V-E, neu)
Preis-Mengen-Regelung
Kumulative Wirkung der Maßnahmen
Herstellerabschlag, Rabattverträge für patentgeschützte Arzneimittel und die Preis-Mengen greifen gleichzeitig und übereinander in die Innovationscluster Onkologie, Autoimmun, Diabetes und Herz-Kreislauf ein. Diese kumulierenden Effekte werden sich un...
Mehrfachbelastung je Cluster
Zwei exemplarische Beispiele wie sich die Kumulation finanziell auswirken wird am Beispiel des statischen Herstellerabschlages
Einordnung und Methodik
Gesetze und Paragrafen
Institutionen, Verbände und Datenquellen
Sparmaßnahmen und Begriffe der Preisregulierung
ATC-Codes der Wirkstoffgruppen
Wirkstoffklassen und medizinische Fachbegriffe
Einheiten und sonstige Abkürzungen
02.07.2026
Datei
BERLIN
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info@pharmadeutschland.de
www.pharmadeutschland.de
BRÜSSEL
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1000 Brüssel
Pressemitteilung
Pharma Deutschland: GKV-Spargesetz trifft
innovative Arzneimittel mehrfach
Mehrfachbelastung gefährdet Versorgung, Innovation
und Investitionen am Standort Deutschland
Berlin (2. Juli 2026) – Die im Entwurf des GKV-
Beitragssatzstabilisierungsgesetzes (GKV-BStabG) vorgesehenen
Sparmaßnahmen treffen insbesondere den patentgeschützten
Arzneimittelmarkt und vor allem Arzneimittel für schwer und
chronisch erkrankte Menschen. Eine aktuelle Analyse von Pharma
Deutschland zeigt, dass mehrere Instrumente gleichzeitig auf
dieselben Arzneimittel wirken und sich in ihrer finanziellen
Belastung gegenseitig verstärken.
Rund 85 Prozent des patentgeschützten Arzneimittelmarktes
entfallen auf Therapien gegen lebensbedrohliche oder schwere
chronische Erkrankungen. Besonders betroffen sind die
Versorgungsbereiche Onkologie, Autoimmun- und
Entzündungserkrankungen, Diabetes sowie Herz-Kreislauf- und
Thromboseerkrankungen. Gerade in diesen Therapiegebieten
greifen künftig mehrere Sparinstrumente parallel, darunter der
dynamische Herstellerabschlag, Rabattverträge für
patentgeschützte Arzneimittel, Preis-Mengen-Regelungen sowie
das verlängerte Preismoratorium.
Die Analyse zeigt, dass die Maßnahmen nicht isoliert wirken,
sondern sich gegenseitig verstärken. Während die Preise
innovativer Arzneimittel bereits im Rahmen des AMNOG-Verfahrens
verhandelt werden, kommen mit dem GKV-BStabG weitere
Abschläge und Preisregulierungen hinzu. Dadurch können einzelne
Präparate gleichzeitig von mehreren Sparinstrumenten betroffen
sein. Die Analyse zeigt, dass insbesondere die Onkologie gleich von
vier verschiedenen Sparinstrumenten betroffen wäre. Auch
Therapien gegen Autoimmun- und Herz-Kreislauf-Erkrankungen
würden gleichzeitig von mehreren Regulierungsinstrumenten
erfasst.
2
„Das GKV-Spargesetz belastet Arzneimittel mit mehreren
Maßnahmen gleichzeitig. AMNOG-Rabatte, Herstellerabschlag,
neue Rabattverträge und Preis-Mengenabschläge greifen
ineinander und schaukeln sich in ihrer Wirkung gegenseitig auf.
Diese Kumulation trifft Therapiefelder, in denen Deutschland heute
versorgungsrelevant und forschungsstark ist. Wer denselben
patentgeschützten Markt gleich mehrfach zur Kasse bittet und so
bei Gesamt-Rabattsätzen landet, die den Umsatz von Präparaten
auf einen Schlag mehr als halbiert, riskiert Versorgungssicherheit
und Innovations- und Investitionskraft am Standort." erklärt
Dorothee Brakmann, Hauptgeschäftsführerin von Pharma
Deutschland. Besonders problematisch sei dabei nicht jede
einzelne Maßnahme für sich, sondern deren gleichzeitiges
Zusammenwirken. Dieses wird die Einführung neuer Therapien
erschweren, die Therapiefreiheit einschränken und Investitionen in
den Pharmastandort Deutschland beeinträchtigen.
Die vollständige Analyse ist dieser Pressemitteilung als PDF-Anlage
beigefügt.
_______________
Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der
Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400
Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und
Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten
Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in
Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken
verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen
Arzneimittel sowie einen Großteil der stofflichen und dentalen
Medizinprodukte für die Patientinnen und Patienten bereit. Unter
www.pharmadeutschland.de gibt es mehr Informationen zu Pharma
Deutschland.
http://www.pharmadeutschland.de/
02.07.2026
Datei
BERLIN
Friedrichstraße 134
10117 Berlin
BONN
Ubierstraße 71–73
53173 Bonn
Pharma Deutschland e. V.
info@pharmadeutschland.de
www.pharmadeutschland.de
BRÜSSEL
Rue Marie de Bourgogne 58
1000 Brüssel
Pressemitteilung
Medizinprodukte-Verordnung: Europäisches
Parlament schlägt konstruktiven Kurs ein
Pharma Deutschland sieht die MDR-Überarbeitung auf
einem guten Weg
Berlin (02. Juli 2026) – Pharma Deutschland begrüßt zahlreiche
Verbesserungen im Berichtsentwurf des federführenden
Ausschusses für öffentliche Gesundheit (SANT) des Europäischen
Parlaments zur Überarbeitung der Medizinprodukte-Verordnung
(MDR). Der heute vorgelegte Entwurf des Berichterstatters Oliver
Schenk greift wesentliche Anliegen der Branche auf und setzt
wichtige Impulse für eine praxistauglichere Regulierung.
„Der Bericht zeigt, dass die Erfahrungen aus der Praxis zunehmend
in der europäischen Gesetzgebung ankommen. Dass zahlreiche
Vorschläge aufgegriffen wurden, ist ein wichtiges Signal. Die
Überarbeitung der MDR bewegt sich damit in die richtige Richtung
– für Patientensicherheit, Innovation und eine verlässliche
Versorgung“ sagt Dorothee Brakmann, Hauptgeschäftsführerin von
Pharma Deutschland.
Positiv bewertet Pharma Deutschland insbesondere, dass der
Berichtsentwurf mehr Rechtssicherheit schaffen will, die stärkere
Einbindung von Herstellern, Benannten Stellen und
Industrieverbänden vorsieht und die Nutzung elektronischer
Gebrauchsanweisungen erleichtert. Auch die vorgesehenen
Anpassungen bei Medizinprodukten mit Arzneimittelbestandteilen
sowie die Bereitstellung bestimmter Informationen in englischer
Sprache für professionelle Anwender gehen aus Sicht des
Verbandes in die richtige Richtung.
„Jetzt gilt es, die Überarbeitung konsequent fortzuführen und die
MDR so zu überarbeiten, dass sie Patientensicherheit und
Innovationsfähigkeit gleichermaßen stärkt", so Brakmann weiter.
Im weiteren parlamentarischen Verfahren sieht Pharma
Deutschland noch punktuellen Verbesserungsbedarf. Dazu
2
gehören insbesondere strukturiertere, transparentere und besser
planbare Verfahren zur Einstufung von Produkten, die Abschaffung
von Rezertifizierungspflichten und praxisgerechte Berichtspflichten.
Darüber hinaus setzt sich Pharma Deutschland weiterhin für
Anpassungen für stoffliche Medizinprodukte sowie gegen die
verstärkte Rolle der Europäischen Arzneimittel-Agentur im
Bewertungsverfahren ein.
Die erste Beratung des Berichtsentwurfs im SANT-Ausschuss ist für
den 14. Juli geplant. Der Ausschuss soll Anfang Dezember über den
Bericht abstimmen. Die Annahme der Position des Europäischen
Parlaments im Plenum wird derzeit für Mitte Dezember erwartet.
_______________
Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der
Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400
Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und
Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten
Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in
Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken
verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen
Arzneimittel sowie einen Großteil der stofflichen und dentalen
Medizinprodukte für die Patientinnen und Patienten bereit. Unter
www.pharmadeutschland.de gibt es mehr Informationen zu Pharma
Deutschland.
http://www.pharmadeutschland.de/
02.07.2026
Datei
