Die Generaldirektion Gesundheit und Lebensmittelsicherheit der Europäischen Kommission (DG SANTE) hat über die Europäische Exekutivagentur für Gesundheit und Digitales (HaDEA) eine „Studie zur Unterstützung der Überwachung der Verfügbarkeit von Medizinprodukten auf dem EU-Markt“ in Auftrag gegeben. Die Studie wurde von einem Konsortium unter Leitung der Gesundheit Österreich GmbH (GÖG) gemeinsam mit Areté und Civic Consulting durchgeführt und lief vom 2. Dezember 2022 bis zum 1. Juni 2026. Untersucht wurden Medizinprodukte und In-vitro-Diagnostika aller Risikoklassen mit besonderem Fokus auf Produkte, für die eine Benannte Stelle eingebunden ist. Die Studie umfasste 31 Länder, darunter die 27 Mitgliedstaaten der Europäischen Union sowie Island, Liechtenstein, Norwegen und die Türkei. Berücksichtigt wurden sowohl bereits auf dem Markt verfügbare Produkte als auch Produkte, die künftig in Verkehr gebracht werden sollen, einschließlich sogenannter „Legacy Devices“ und neuer Produkte nach MDR bzw. IVDR. Im Rahmen der Studie wurden bereits zwei Umfragen durchgeführt. Die Ergebnisse wurden in einem öffentlichen Dashboard sowie in Form einer PowerPoint-Präsentation ( erste Umfrage 2023, zweite Umfrage 2024) veröffentlicht. Anfang 2026 wurde eine dritte Umfrage durchgeführt, um weitere Informationen zum Stand der Umsetzung der Verordnung (EU) 2017/745 über Medizinprodukte (MDR) und der Verordnung (EU) 2017/746 über In-vitro-Diagnostika (IVDR) zu erheben. Die Datenerhebung bei Herstellern von Medizinprodukten und In-vitro-Diagnostika, Bevollmächtigten, Importeuren und Händlern erfolgte auf Basis von Informationen bis zum 31. Oktober 2025. Insgesamt gingen 213 berücksichtigungsfähige Antworten ein, darunter 152 von Herstellern von Medizinprodukten. Die Ergebnisse der dritten Umfrage wurden am 3. Juli 2026 veröffentlicht. 81 Prozent der teilnehmenden Unternehmen stammen aus der Europäischen Union. Von den befragten Medizinprodukteherstellern beschäftigen 76 Prozent weniger als 250 Mitarbeitende; 56 Prozent sind Klein- oder Kleinstunternehmen. Zudem gaben 71 Prozent der Unternehmen an, ihre Produkte sowohl innerhalb als auch außerhalb der Europäischen Union zu vertreiben. Die Umfrage liefert darüber hinaus aktuelle Erkenntnisse zu den MDR-Zertifizierungsverfahren. Bei 44 Prozent der Medizinproduktehersteller dauert die Vorbereitung eines MDR-Antrags sechs bis zwölf Monate, bevor dieser bei einer Benannten Stelle eingereicht wird. Weitere 39 Prozent benötigen hierfür mehr als 13 Monate. Bei 42 Prozent der Unternehmen vergehen mehr als drei Monate zwischen der Antragseinreichung und dem Abschluss einer schriftlichen Vereinbarung mit der Benannten Stelle. 54 Prozent der Hersteller berichten, dass es mehr als 19 Monate dauert, eine MDR-Zertifizierung zu erhalten. Auch die Kosten der MDR-Umsetzung wurden untersucht. Die Ergebnisse zu den Aufwendungen für klinische Bewertungen sowie für QMS- und MDR-Zertifikate sind in den Folien 53 bis 55 der Präsentation dargestellt. Hinsichtlich der Umstellung bestehender Produktportfolios auf die MDR zeigte die Umfrage ein gemischtes Bild. 38 Prozent der Befragten gaben an, dass weniger als 10 Prozent ihres umzustellenden Produktportfolios bereits MDR-zertifiziert sind. Demgegenüber haben 35 Prozent der Unternehmen bereits zwischen 91 und 100 Prozent ihres betreffenden Portfolios nach MDR zertifizieren lassen. Besonders hervorzuheben sind die Ergebnisse zu Marktrücknahmen. 48 Prozent der Befragten erklärten, seit 2021 die Produktion, Vermarktung oder Lieferung bestimmter Produkte auf dem EU-Markt eingestellt zu haben. Sieben Prozent dieser Produkte waren Nischenprodukte. Als häufigster Grund wurde genannt, dass die erzielten Umsätze die Kosten einer erneuten Zertifizierung gemäß MDR nicht rechtfertigen. Die Ergebnisse bestätigen erneut die langen Zertifizierungszeiträume und den hohen Aufwand der MDR-Umsetzung, insbesondere für kleine und mittlere Unternehmen. Gleichzeitig verdeutlichen sie die weiterhin bestehenden Risiken für die Verfügbarkeit einzelner Medizinprodukte auf dem europäischen Markt.
06.07.2026
Beitrag
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
Jeden Monat veröffentlicht die Europäische Arzneimittel-Agentur (EMA) einen Überblick über alle Sicherheitssignale, die in der letzten Sitzung des Ausschusses für Risikobewertung im Bereich der Pharmakovigilanz (PRAC) erörtert wurden sowie über die jeweiligen Empfehlungen. Die Übersicht enthält PRAC-Empfehlungen für zentral und national zugelassene Arzneimittel. Eine Liste mit allen seit September 2012 vom PRAC diskutierten Sicherheitssignalen ist verfügbar. Die Empfehlungen beinhalten die Aspekte „Aktualisierung der Produktinformation“, „Bereitstellung zusätzlicher Informationen“ sowie „andere Empfehlungen“. PRAC-Empfehlungen für regulatorische Maßnahmen (z. B. Änderung der Produktinformation) werden dann zunächst zur Bestätigung an den Ausschuss für Humanarzneimittel (CHMP) übermittelt, wenn das Signal zentral zugelassene Produkte betrifft, und an die Koordinierungsgruppe für gegenseitige Anerkennung und dezentralisierte Verfahren - Human (CMDh), wenn es sich um national zugelassene Produkte handelt. Gemäß Artikel 16 Absatz 3 der Verordnung (EU) Nr. 726/2004 und Artikel 23 Absatz 3 der Richtlinie 2001/83/EG müssen Zulassungsinhaber ihre Produktinformationen auf dem neuesten Stand der wissenschaftlichen Erkenntnisse halten. Von den Zulassungsinhabern wird also erwartet, dass sie entsprechend den Empfehlungen des PRAC (bzw. des CHMP/der CMDh) tätig werden.
06.07.2026
Beitrag
PD
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© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.
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
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PD
Ab dem 1. September 2026 steht die neue PharmNet.Bund-Anwendung zur Beantragung von Eingangsnummern (ENR) und EU-Verfahrensnummern (EUV) für nationale Verfahren sowie MRP und DCP zur Verfügung. Die erforderlichen Nummern können künftig vor Einreichung eines Zulassungsantrags automatisiert über ein digitales Formular angefordert werden. Die bislang genutzte Beantragung per E-Mail entfällt. Im Rahmen einer gemeinsamen Informationsveranstaltung stellen BfArM und PEI die neue Fachanwendung vor und erläutern die Regelungen zur Beantragung von ENR und EUV, die Voraussetzungen für die Nutzung sowie die grundlegenden Funktionalitäten des Systems. Für die Nutzung der Anwendung ist eine einmalige Registrierung im PharmNet.Bund-Portal über das System „Registrierung und Benutzerverwaltung“ (RuBen) erforderlich. Die kostenfreie Online-Veranstaltung findet am 4. August 2026 um 14 Uhr statt. Eine Anmeldung ist bis zum 31. Juli 2026 über das PharmNet.Bund-Portal möglich. Weitere Informationen sind dem Infoschreiben zu entnehmen. Die Anmeldung zur Veranstaltung finden Sie auf der BfArM-Website .
06.07.2026
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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.
Das digitale Formular „Beantragung ENR und EUV“ im PharmNet.Bund-Portal
ermöglicht dem pharmazeutischen Unternehmen vor Antragsstellung die
erforderliche ENR und/oder EUV automatisiert anzufordern. Die bisherige
Beantragung per E-Mail wird durch die PharmNet.Bund Anwendung abgelöst. Ab
dem 01. September 2026 sind alle Antragstellenden gebeten, das digitale Formular
im PharmNet.Bund-Portal zu nutzen.
Registrierung
Für die Nutzung der PharmNet.Bund-Fachanwendung ist eine einmalige
Registrierung im System „Registrierung und Benutzerverwaltung“ (RuBen) im
PharmNet.Bund-Portal erforderlich – mit der Berechtigung „PharmNet.Bund-
Anwendung Formulareinreichung“. Informationen zum Ablauf der Registrierung sowie
die Registrierung selbst finden Sie auf der verlinkten Website im PharmNet.Bund-
Portal.
https://www.pharmnet-
bund.de/PharmNet/DE/Service/Benutzerverwaltung/ node.html
Informationen zur Anwendung „Formulareinreichung“
Vor der Einreichung eines Zulassungsantrages ist für die oben genannten
Zulassungsverfahren vom pharmazeutischen Unternehmen eine ENR und/oder eine
EUV zu beantragen. Die relevanten Nummern sollten vom Antragstellenden
frühestens ca. vier Wochen vor der Einreichung beantragt werden.
Die Nummern werden über das digitale Formular automatisch vergeben. Sobald die
beantragten Nummern bereitstehen, erfolgt (ggf. mit zeitlicher Verzögerung) eine
automatische E-Mail-Benachrichtigung an den Antragstellenden.
Seite 2/2
Die ENR und die EUV sollten immer im Cover Letter sowie bei jedem Schriftverkehr
mit der jeweiligen Bundesoberbehörde angegeben werden.
Informationsveranstaltung
Am 04. August 2026 um 14 Uhr bieten das Paul-Ehrlich-Institut und das BfArM eine
gemeinsame Informationsveranstaltung zur Beantragung von ENR und EUV an. Eine
vorherige Anmeldung zur Teilnahme ist erforderlich. Melden Sie sich bitte bis
spätestens 31. Juli 2026 bei der entsprechenden Veranstaltung im PharmNet.Bund-
Portal an.
Schulungen und Informationsveranstaltungen für PharmNet.Bund-Anwendungen
06.07.2026
Datei
PD
Die Generaldirektion Gesundheit und Lebensmittelsicherheit der Europäischen Kommission (DG SANTE) hat über die Europäische Exekutivagentur für Gesundheit und Digitales (HaDEA) eine „Studie zur Unterstützung der Überwachung der Verfügbarkeit von Medizinprodukten auf dem EU-Markt“ in Auftrag gegeben. Die Studie wurde von einem Konsortium unter Leitung der Gesundheit Österreich GmbH (GÖG) gemeinsam mit Areté und Civic Consulting durchgeführt und lief vom 2. Dezember 2022 bis zum 1. Juni 2026. Untersucht wurden Medizinprodukte und In-vitro-Diagnostika aller Risikoklassen mit besonderem Fokus auf Produkte, für die eine Benannte Stelle eingebunden ist. Die Studie umfasste 31 Länder, darunter die 27 Mitgliedstaaten der Europäischen Union sowie Island, Liechtenstein, Norwegen und die Türkei. Berücksichtigt wurden sowohl bereits auf dem Markt verfügbare Produkte als auch Produkte, die künftig in Verkehr gebracht werden sollen, einschließlich sogenannter „Legacy Devices“ und neuer Produkte nach MDR bzw. IVDR. Im Rahmen der Studie werden regelmäßig Umfragen bei den Benannten Stellen durchgeführt. Die Ergebnisse werden in einem öffentlichen Dashboard veröffentlicht und sollen die Entwicklung der Zertifizierungsaktivitäten sowie die Verfügbarkeit von Medizinprodukten und In-vitro-Diagnostika auf dem europäischen Markt überwachen. Anfang 2026 wurde eine 20. Umfrage durchgeführt, um weitere Informationen zum Stand der Umsetzung der Verordnung (EU) 2017/745 über Medizinprodukte (MDR) und der Verordnung (EU) 2017/746 über In-vitro-Diagnostika (IVDR) zu erheben. Die Datenerhebung bei den Benannten Stellen erfolgte auf Basis von Informationen bis zum 28. Februar 2026. An der Umfrage beteiligten sich alle 53 gemäß MDR und IVDR Benannten Stellen. Die Ergebnisse wurden am 3. Juli 2026 veröffentlicht. Die Umfrage zeigt den aktuellen Stand der MDR-Zertifizierungen. Insgesamt wurden 32.898 MDR-Anträge und 18.010 MDR-Bescheinigungen erfasst. Im Vergleich zur vorherigen Erhebung vom Oktober 2025 hat sich die Zahl der Anträge kaum verändert (33.107), während die Zahl der ausgestellten MDR-Bescheinigungen leicht zunahm (17.507). Die Auswertung enthält zudem detaillierte Angaben zu Anträgen und Zertifizierungen nach Anhängen der MDR sowie nach Art der Konformitätsbewertung (Qualitätsmanagementsysteme und Produktzertifizierungen). Darüber hinaus wurden 1.175 Anträge für Produkte nach Regel 14 MDR gemeldet. Für diese Produkte wurden bislang 387 Zertifikate ausgestellt. Für Produkte nach Regel 21, erster Spiegelstrich, wurden 162 Anträge registriert. Zum Zeitpunkt der Datenerhebung war hierfür noch kein Zertifikat ausgestellt worden. Die Umfrage liefert außerdem aktuelle Erkenntnisse zu der Dauer der Zertifizierungsverfahren. Nach Angaben von 52 Benannten Stellen vergehen im Durchschnitt weniger als zwei Monate zwischen der Einreichung eines Antrags und der Unterzeichnung einer schriftlichen Vereinbarung mit dem Hersteller. Hinsichtlich der Dauer bis zur Zertifikatserteilung zeigt die Umfrage, dass bei 51 % der Einreichungen zwischen 13 und 18 Monate bis zur Ausstellung eines MDR-Zertifikats für Qualitätsmanagementsysteme und Produkte vergehen. Im Oktober 2025 lag dieser Anteil bei 53 %. Insgesamt benötigen 92 % der Verfahren mehr als 13 Monate bis zur Ausstellung eines MDR-Zertifikats. In der vorherigen Erhebung lag dieser Wert bei 89 %. Für Qualitätsmanagementsysteme (QMS) geben 62 % der Benannten Stellen eine Verfahrensdauer von 13 bis 18 Monaten an. Die Ergebnisse verdeutlichen, dass MDR-Zertifizierungsverfahren weiterhin einen erheblichen Zeitaufwand erfordern und sich die Verfahrensdauern gegenüber der vorherigen Erhebung kaum verändert haben.
06.07.2026
Beitrag
PD
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
Die Europäische Kommission beabsichtigt in ihrem Vorschlag für eine Verordnung zur Änderung der MDR und IVDR, die maximale Gültigkeitsdauer von Zertifikaten abzuschaffen. Anstelle einer erneuten Zertifizierung von Produkten sollen benannte Stellen regelmäßige Überprüfungen durchführen, die dem Risiko des Produkts angemessen seien. Dies erfordert eine zuverlässige Risikobewertung auf der Grundlage eines systematischen Verfahrens. Eine verstärkte Überwachungsintensität zu Beginn bildet die Grundlage für die Bewertung der Risiken, die mit einem bestimmten Medizinprodukt und seinem Hersteller verbunden sind, sowie für die Festlegung des künftigen Überwachungsniveaus auf der Grundlage dieser Bewertung. Aus diesem Grund hat das Team-NB ein Positionspapier mit einem ergänzenden Vorschlag veröffentlicht, in dem es seine Standpunkte und Änderungsvorschläge zur Anpassung des Überwachungssystems im Hinblick auf den Vorschlag der Kommission zur Aufhebung der maximalen Gültigkeitsdauer von Zertifikaten darlegt. Das Positionspapier enthält Einzelheiten zur Umsetzung der risikoadaptiven Überwachung von Medizinprodukten und Herstellern durch benannte Stellen. Zu den betroffenen Überwachungsmaßnahmen, deren Häufigkeit und Kriterien entsprechend dem geltenden Grad der risikoadaptiven Überwachung festzulegen sind, gehören insbesondere: Überwachungsaudits unangekündigte Audits Stichprobenentnahmen im Rahmen der Überwachung.
06.07.2026
Beitrag
PD
Dem Protokoll der Sitzung sind folgende thematische Schwerpunkte zu entnehmen: Umsetzung der SoHO-Verordnung (EU) 2024/1938 Regulatorische Auslegung und Q&A-Dokumente Inspektionen und Notfallplanung Import von Plasma, Gameten und Embryos Entwicklung der EU-SoHO-Plattform EU4Health-Projekte zur Unterstützung der Umsetzung der SoHO-Verordnung Zusammenarbeit mit EDQM, ECDC und EMA Ein Schwerpunkt des Meetings lag auf der Verabschiedung neuer regulatorischer Hilfestellungen für die Mitgliedstaaten. So wurde ein umfangreicher Fragen- und Antwortenkatalog (Q&A) mit 39 neuen Auslegungen angenommen, darunter auch Leitlinien zur Überwachung von Aktivitäten im Zusammenhang mit Plasma Master Files. Zudem billigte das Board eine Kommunikationsstrategie, die den Übergang von bisher unter anderen Rechtsrahmen regulierten Tätigkeiten und Produkten in den Anwendungsbereich der SoHO-Verordnung unterstützen soll. Auch neue Inspektionsleitlinien wurden abgestimmt, um den zuständigen Behörden einen harmonisierten Rahmen für die Überwachung von SoHO-Einrichtungen bereitzustellen. Weitere Diskussionen befassten sich mit Notfallplänen für die Sicherstellung der Versorgung, den nationalen Vorbereitungen zur praktischen Umsetzung der Verordnung sowie Fragen zur Festlegung von Höchstgrenzen für Gametenspender. Zudem wurden Herausforderungen beim Import von Gameten und Embryonen aus Drittstaaten sowie beim Import von Plasma zur Fraktionierung erörtert. In mehreren Fällen sollen weitere Empfehlungen und Lösungsansätze durch die zuständigen Arbeitsgruppen erarbeitet werden. Die Arbeitsgruppen des SCB informierten über laufende Aktivitäten, insbesondere zur Registrierung und Zulassung von SoHO-Einrichtungen, zur Datenerhebung sowie zur Versorgungssicherheit. Darüber hinaus berichteten EDQM und ECDC über aktuelle Entwicklungen in ihren jeweiligen Arbeitsbereichen. Einen weiteren Schwerpunkt bildeten die Fortschritte bei der EU-SoHO-Plattform, die künftig die Verwaltung von Einrichtungen, Präparationen und Datenmeldungen unterstützen soll. Außerdem wurden mehrere EU4Health-Projekte vorgestellt, darunter IMPLEMENT SoHO und SHARE SoHO, die die praktische Umsetzung der neuen Verordnung begleiten und die Zusammenarbeit der Mitgliedstaaten fördern sollen. Der Termin für die nächste Sitzung wurde noch nicht bekannt gegeben.
06.07.2026
Beitrag
