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
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