Notified Body Survey on Certificates & Applications under the Medical Devices/IVD Regulation

The results of a survey of 39 notified bodies were published by the EU Commission at the end of 2023. It concerns certifications and applications under the Medical Device/IVD Regulations (MDR/IVDR). What are the results?

The study, which was launched on December 2, 2022 and will run until December 1, 2025, provides an overview of the availability of medical devices and in-vitro diagnostics. The document is very comprehensive and comprises 39 slides. The data comes from notified bodies recognized under the MDR/IVDR. The data is from July 2023 and was collected from 39 Notified Bodies. Of these 29 of the Notified Bodies are accredited under the MDR, 9 under MDR and IVDR and one under IVDR. The data is prepared in great detail. For example, applications and certificates are presented in graphical form according to the various annexes and compared at fixed points in time. Data on combination products ("devices incoporating a medicinal substance") are also listed, for example.

The reasons for rejecting an MDR application are interesting. 75% of applications are rejected because

• the application is outside the scope of a notified body (47%)
• the application is not complete (27%)

The time periods for obtaining a new certificate are also of interest (quality management system (QMS) vs. quality management system and product)

• 45% of notified bodies manage to issue a new QMS certificate within 6-12 months
• 39% need more than 13 months to issue a new QMS certificate (longest period was 24 months)

Issuing certificates took longer when it came to the quality management system and product

• 40% of notified bodies take between 13 and 18 months to issue a new product certificate
• 71% of notified bodies need at least 13 months or longer to do so.

It usually takes 1-3 months from the application to the signing of a written contract between customers and Notified Bodies (based on feedback from 34 Notified Bodies). There is then more detailed information on in-vitro diagnostics.

The comprehensive results of the survey can be viewed on the EU website.

The EU Commission is also publishing an overview ("dashboard") of the results regarding the availability of medical devices and IVDs in the EU.