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in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates.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 NBs & Certificates module is already available and can be used voluntarily. Nevertheless, the Commission is not in a position to require the use of the Actor registration module until the transition periods laid down in Regulation (EU) 2024/1860 expire. Additional national requirements on registrations can therefore not be excluded.
Therefore, in EUDAMED, NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) on voluntary basis.
Some elements referenced in the certificate, need to be first registered in EUDAMED. These would include the manufacturer, the authorised representative (where applicable), the system-procedure pack producer and the Basic UDI-DI(s).
Infographics
Documentation
- The EUDAMED Information Centre contains the relevant updated documentation
Guidance
- Guidance on the application of legislation, particularly in the Notified Bodies and EUDAMED sections
