EUDAMED entry into force | Update

There have been some recent changes regarding EUDAMED timeline

There have been some recent changes regarding EUDAMED timeline
July 12, 2022

Manufacturers, authorized representatives, system/procedure pack producers and importers of MDR compliant medical devices, as well as notified bodies… ATTENTION!

The European Commission has recently announced a new delay in the entry into force of EUDAMED.

The updated timeline has the following changes:

  • The mandatory registration in the actors, vigilance, clinical investigation and performance studies and market surveillance modules is postponed from Q4 2023 to Q4 2024.
  • The mandatory registration in the UDI/device and notified bodies and certificate modules is postponed from Q2 2025 to Q2 2026.

 

In case you need further information, you can contact us at: info@asphalion.com

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