The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today.

Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined below:

  • Actor Registration Module – Already live.
  • Device Registration (UDI) Module – This Will be released into production in September 2021. Voluntary use is possible and workable.
  • Notified Bodies and Certificates Module – This Will be released into production in September 2021 with the exception of the CECP and the Mechanism for scrutiny, which will remain in the playground for testing.
  • Vigilance and CI/PS Modules – Will not be released into production until EUDAMED is ‘fully-functional. Will be released into the Playground environment only.
  • Market Surveillance Module – This could be released into production before EUDAMED is fully functional. Consideration is being weighed against the limited time period between the development of this module and the full functionality of EUDAMED.

 

As the COM has indicated, these modules will now be implemented asynchronously and there will not be a single date of mandatory compliance.

While a phased approach to the roll-out may present a longer timeline, it also represents an opportunity to properly prepare for implementing M2M data exchange with EUDAMED when mandatory compliance takes place.

Innovit will continue to stay in the loop on any progress of EUDAMED.  Check back here regularly for updates.  Stay tuned!