Notified Bodies and Certificates
The European Commission has released updated documents on the technical documentation relevant for Notified Bodies and the related registration of certificates in EUDAMED.
As stated in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), Notified Bodies should register in EUDAMED information regarding certificates issued, suspended, reinstated, withdrawn or refused and other restrictions on these certificates. However, EUDAMED is not fully functional and therefore, the use of the NBs and Certificate module is not mandatory.
Currently, NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) in EUDAMED on a voluntary basis. This is possible only if all of the parties mentioned in the certificates are registered, also on a voluntary basis, in EUDAMED.
- EUDAMED Certificates data dictionary
- EUDAMED Refused Certificate and Application data dictionary
- Certificate business rules
- Certificate enumerations
- DTX Service Definition for Notified Bodies
- NBs – Data Exchange Notes
- NB – XML samples
The European Commission has released updated documents on the UDI/Devices registration module in EUDAMED.
MDR and IVDR introduce a device identification system based on a unique device identifier (UDI) to facilitate the traceability of medical devices. As the UDI module of EUDAMED is not fully functional, manufacturers can enter UDI/Device information on a voluntary basis. The registration of devices will need to be completed within 24 months after the Commission has published a notice that EUDAMED is fully functional, which is expected in May 2023.
- EUDAMED UDI/Device data dictionary
- UDI Device Business rules
- UDI Device enumerations
- DTX service definition for economic operators
- Economic Operators DTX notes
- EO – XML samples
- UDI Devices User Guide – Update April 2022
You can find the full document in our Library of documents – MDCG icon.