[2025-07-25] (Open Access) The European Commission continues to publish the results of its survey of Notified Bodies (NBs) with regard to the availability of medical devices (MDs) and in vitro diagnostic medical devices (IVDDs), on the European Union (EU) market. This is the 14th update.
Survey background
The survey was commissioned by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE). It was entrusted to a consortium led by the Austrian National Institute of Public Health (Gesundheit Österreich GmbH / GÖG), in collaboration with Areté and Civic Consulting.
The overall aim of the study is to monitor the availability of MDs and IVDDs on the EU market, in the context of the implementation of the new Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), from the perspective of key stakeholders. Scheduled to last 36 months, the study is due to conclude in December 2025.
The July 25, 2025 presentation, entitled “Study supporting the monitoring of the availability of medical devices on the EU market – Survey results of the 14th NB survey (MDR/IVDR) with data status 28 February 2025”, summarizes the latest feedback from surveyed NBs.
This study is the subject of regular articles in the DMEXPERTS network. For example, you can read our latest article on the subject.
Results presentation
This 56-slide presentation compiles all the results of this 14th survey of NBs, in a succession of tables and graphs. It deals with small and medium datasets, each corresponding to a set of questions asked to NBs periodically.
First of all, it is gratifying to note that 100% of the 51 NBs contacted responded to the survey. The data presented reflect the situation as of
For medical devices:
- 18,476 written agreements were signed between NBs and manufacturers, in particular under the transitional arrangements for legacy devices;
- 28,489 certification applications were accepted under MDR and 12,177 EU certificates issued under MDR. For the first time, the (still very large) gap between applications and certificates issued is starting to narrow;
- In the majority of cases (64%), less than two months elapsed between the submission of the application and the signing of a written agreement with the NB;
- Annex IX of the MDR remains the preferred route for conformity assessment;
- The vast majority of submissions are still incomplete. Only 15 NBs report that at least 50% of submissions are considered complete;
- The time it takes to obtain certification (quality management system and device) is still very long:
- 6 to 12 months for 9% of NBs,
- From 13 to 18 months for 60% of NBs,
- From 19 to 24 months for 29% of NBs.
- For non-medical devices under Annex XVI: still very few certificates have been issued;
- To date, no certificates have been issued for the reprocessing of single-use devices.
For in vitro diagnostic medical devices:
- 1195 written agreements were signed between NBs and manufacturers;
- 2395 applications for certification were accepted under IVDR, and 1490 certificates issued under IVDR. Here too, the gap seems to be closing;
- In the majority of cases (66%), less than two months elapsed between the submission of the application and the signing of a written agreement with the NB;
- Annex IX of the IVDR also remains the preferred route for conformity assessment;
- Here too, the files submitted are very incomplete;
- The time required to obtain certification (quality management system and device) is also very long for IVDDs:
- 6 to 12 months for 27% of NBs,
- From 13 to 18 monthsfor 64% of NBs,
- From 19 to 24 months for 9% of NBs.
- 29% of NBs (4 out of 14) have collaborated at least once with one of the EU Reference Laboratories (EURLs), as part of an application for certification of a class D IVDD, since October 1, 2024.
Designation codes covered by NBs
In parallel with this study, the European Commission also published another presentation in June 2025. Entitled “Coverage of designation codes by MDR/IVDR notified bodies”, it features several graphs of the codes covered by the various notified bodies, for MDs and IVDDs.
As a reminder, Implementing Regulation (EU) 2017/2185 lists these codes in Annexes I (for MDs) and II (for IVDDs).
In summary, we can see that:
- For MDs:
- Two-thirds of the codes (MDA, MDN, MDS, MDT) are covered by at least 35 NBs;
- Several codes are sorely lacking in coverage, with fewer than 10 NBs designated: the four active implantable MD codes (MDA0101 to MDA0104) and code MDS1002 for MDs manufactured from human tissue. Unsurprisingly, these are MDs with high risk factors.
- For IVDDs:
- Almost half (47.5%) of the codes are covered by all 17 NBs;
- 80% of codes are covered by 14 or more NBs;
- As with MDs, 9 “risk” codes are under-represented, with fewer than 10 NBs designated: IVR0101 to 0106 (blood typing), IVR0201 and 0202 (tissue typing), IVP3009 (IVDDs requiring knowledge of radioactivity measurement) and IVD4003 (IVDDs requiring knowledge of transmissible agent detection).
Conclusion
Here, we’ve taken a brief look at the results of the study. For further information, we invite you to take a closer look at the presentation slides. In particular, you’ll find the results of previous surveys, enabling you to follow their evolution over time.
A dynamic dashboard is also available for all data. Several tabs and drop-down menus allow you to view the information you are looking for. Data for April 2025 are already visible.
Although this study highlights the gap between applications and certificates issued, the efforts made are beginning to bear fruit. It also highlights the need for manufacturers to improve the quality of their submissions.
Article written by Christophe Saillet, member of the DMEXPERTS network.