EUDAMED or the European database on medical devices has been designed to support the implementation of the EU Medical Devices Regulations.
EUDAMED is composed of 6 modules and in the beginning of October 2021, the EC has made available new modules covering UDI/Device Registration and Notified Bodies & Certificates. Today, some helpful documents were released to support the users, for example the Notified Body User Guide.
In this new module of EUDAMED, Notified Bodies will be submitting the Certificates issued as well as Summaries of Safety and Clinical Performance (SSCP). It will be possible to look up what kind of certificates have been issued and if they are still valid, as the Notified Bodies will need to include the amendments, supplements and information whether their certificates have been suspended, reinstated, withdrawn or refused or any other restrictions imposed on them.
The information of this module will be made available to the public and this could be another step towards increasing transparency in the context of the MDR.
Nevertheless, the use of EUDAMED and this module is voluntary until the fourth quarter of 2022, the date when the EC expects its full functionality. In addition, registration of Certificates is only possible provided that all of the parties referenced in the certificates are first registered in the actor module of EUDAMED, which remains voluntary.
All the newly published documents were added to our MDlaw Library of Documents EUDAMED and Notified Body categories:
- Certificates (EC)
- Notified Bodies User Guide (EC)
- EUDAMED Certificates data dictionary (EC)
- EUDAMED Refused Certificate and Application data dictionary (EC)
- Certificate business rules (EC)
- Certificate enumerations (EC)
- DTX Service Definition for Notified Bodies v2.0 (EC)
- NBs – Data Exchange Notes – v2.0 (EC)
- NB – XML samples v2.0 (EC)
Do not forget to follow us on LinkedIn!