Eudamed upcoming plans

The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been done.

They have decided to launch the database simultaneously for both medical devices and in-vitro diagnostics come May 2022.

This means that device manufacturers can now postpone their entering of data into Eudamed.

As compared to the current database, the new Eudamed2 will contain different modules

  • Actors
  • Unique Device Identifiers
  • Notified bodies and certificates
  • Vigilance clinical investigation performance studies
  • Market surveillance