EUDAMED update on timelines

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

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