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in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates.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 Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices has declared this module functional and, in accordance with the transitional provisions set out in Regulation (EU) 2024/1860 ; as from 28 May 2926 the NBs & Certificates module is mandatory to use.
Notified Bodies can enter information in the system on a voluntary basis since October 2021. 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
- IVDR conformity assessments table
- MDR conformity assessments table
- Data for Certificates
- Reasons for status changes
- Refusal of a certificate
Guidance
- Guidance on the application of legislation, particularly in the Notified Bodies and EUDAMED sections
