Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. Such information is accessible to the public.
The European Commission is not in a position to require the use of the NBs & Certificates module until EUDAMED is fully functional according to the Medical Device Regulation.
Therefore, in EUDAMED, NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) only on voluntary basis if all of the parties referenced in the certificates are first registered, also on a voluntary basis, in this database. The parties to be registered would include the manufacturer, the authorised representative (where applicable), and/or the system procedure pack producer and the Basic UDI-DI(s) referenced. However, additional national requirements cannot be excluded.
Relevant documents and links on certificate registration are published below.
- EUDAMED Certificates data dictionary
- EUDAMED Refused Certificate and Application data dictionary
- Certificate business rules
- Certificate enumerations
- DTX Service Definition for Notified Bodies v2.0
- NBs - Data Exchange Notes - v2.0
- NB - XML samples v2.0
- Guidance on the application of legislation, particularly in the Notified Bodies and EUDAMED sections