Survey of Notified Bodies on the Certification Procedure for Medical Devices

The EU Commission regularly publishes overviews of surveys conducted by Notified Bodies (NBs) regarding their certification procedures. What are the results of the latest survey?

The current survey is entitled 'Study supporting the monitoring of the availability of medical devices on the EU market - 14th NB Survey (MDR/IVDR)'. As the title suggests, this is now the 14th survey on this topic. Medical devices and in vitro diagnostics (IVD) are evaluated. A total of 51 Notified Bodies took part in the survey.

The aim of the survey was to provide an overview of the availability of medical devices on the EU market with regard to the implementation of the regulations for medical devices and IVDs. The results are available in a comprehensive dashboard. In addition, a set of slides (56 slides in total) shows the survey results based on data up to the end of February 2025.

Below is a brief summary of the results with a conclusion.

Results for medical devices (MDR)

• Total number of MDR applications submitted: 28,489 (as of 02/2025).
• Certificates: 12,177 issued.
• Rejected applications: 650 (most common reasons: incomplete applications (39%), outside the NB scope (26%)).
• Average time to contract signing: < 2 months in 64% of cases.
• Time to new certificates: QMS: mostly 13-18 months, 36% 6-12 months; QMS + product: mostly 13-18 months, 29% 19-24 months.
• Time allocation NB vs. manufacturer: Ø 42% NB, 58% manufacturer.
• Annex XVI products (without medical purpose): low number of applications/certificates; no certificate for reprocessing of single-use products.
• Article 117 MDR: Increasing number of enquiries and NB opinions issued.

Results In vitro diagnostics (IVDR)

• Total number of applications submitted: 2,395 (as of 02/2025).
• Certificates: 1,490 issued.
• Rejected applications: 12 (mostly 'other reasons' such as withdrawal by manufacturers or unresolved non-conformities).
• Average time to contract signing: < 2 months in 66% of cases.
• Time to certification: QMS: mostly 6-12 months; QMS + product: mostly 13-18 months.
• Time allocation NB vs. manufacturer: Ø 39% NB, 61% manufacturer.
• Class D devices: 765 applications, 466 certificates.
• Cooperation with EU reference laboratories (EURLs) established, especially for hepatitis, retro and respiratory viruses.

Conclusion

• The number of applications is rising steadily, especially for MDR products.
• Certification remains a lengthy process, particularly for complex products (typically 13-18 months).
• High workload due to incomplete or incorrect applications.
• Strong participation of NBs in the survey: All 51 responded (100%).
• Particular challenges: Annex XVI products, reprocessing of single-use products (still without certificates), Class D IVDs with the involvement of EU reference laboratories (EURL).

The entire set of slides can be viewed on the EU Commission website.