The European Commission has announced recently that the EUDAMED UDI/Devices and NBs and Certificates modules are now ready. Specifically, the UDI/Devices module is probably of interest for many manufacturers as it is the part where manufacturers will have to register their products and the belonging UDI codes under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices (MDR and IVDR) respectively.
Together with the actor registration module, three out of six parts of EUDAMED are now live. It is expected that the database will be fully operative in spring 2022.
The Commission’s notification also makes clear that the manufacturers may start entering data on a voluntary basis. This is in line with article 123 of the MDR and associated guidance documents. mdi Europa nonetheless strongly recommends to start working with the new module and use the time to familiarize with the new registration mechanisms.
We anticipate that local country registrations and MDD/ IVDD registration mechanisms will remain in place as long as the use of the EUDAMED database is voluntary.
Source: European Commission
Accompanying this subject we recommend the following content on our website
- Updated EUDAMED implementation dates
- Most Important Changes on MDR
- Major Aspects of the MDR
- MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality
- Voluntary registration with EUDAMED database – industry fears duplicate registrations
- New website on actor registration in EUDAMED 3 available
- Device Registration and Legacy Devices