The European Commission has published new timelines related to EUDAMED. The Commission expects EUDAMED to be fully functional in Q2 of 2023. The corresponding publication in the Official Journal of the European Union (OJEU) will mark the date by when deadlines for an obligatory use of the corresponding modules will become applicable.
6 months after the publication notice, the use of the economic actor, vigilance, clinical investigation/ performance studies and market surveillance modules will become mandatory. 24 months after the publication date, the UDI/ Device registration and Notified Body/ Certificate modules will become mandatory.
We highly suggest to closely monitor the development of EUDAMED and also national registrations in local European countries in the interim. Should you have any questions or concerns, please don’t hesitate to get in touch.
Source: European Commission
Accompanying this subject we recommend the following content on our website
- EUDAMED UDI/Devices and NBs/Certificates modules now live
- Updated EUDAMED implementation dates
- 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