EUDAMED: State-of-play

Despite projections that it will be possible to perform device and Certificate registration directly to EUDAMED from May 2021 – aligning with the MDR date of application – the European Commission has now confirmed that the second and third module of EUDAMED will become active by September 2021.

  • Second module: UDI/device registration
  • Third module: module on Certificates and Notified Bodies

Other modules (on vigilance, clinical investigations, etc.) will be displayed later on, as soon as they are functional.

Please be reminded that actor registration is possible from 1 December 2020, as we reported here.

Recently issued MDCG Guidance comes very handy, as it presents alternative solutions and practices until EUDAMED is fully functional. You can read about it here on our blog.

You can find all EUDAMED relevant and useful documents in our Library of Documents.

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