Updated EUDAMED Timeline for Modules

The European Commission (EC) has published an updated EUDAMED timeline in relation to the roll out of the applicable Modules.

The updated EUDAMED timeline is the following:

At this moment in time, three Modules in EUDAMED are available and may be used:

• • Actor Registration Module available since December 2020
  • UDI/device Registration Module available since October 2021
  • Notified Bodies and Certificates Module available since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities.

The remaining Modules related to Vigilance, Clinical Investigation & Performance Studies, and Market Surveillance, are currently under development and will be launched in the near future, when EUDAMED becomes fully functional.

Please note that at this moment in time the use of EUDAMED is not mandatory nor required. Nevertheless, it is highly encouraged by Notified Bodies, Competent Authorities, and other stakeholders. Henceforth, MedEnvoy highly encourages Manufacturers to register themselves and their devices in EUDAMED.

The above roadmap may be download here.

For more information, you may read about EUDAMED on the European Commission website.

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If you have any questions about the European Commission’s updated EUDAMED timeline, or registering your medical device in EUDAMED, contact us so our regulatory team can help you.

Learn how MedEnvoy can assist you:

• • EU Authorized Representative
  • EU Regulatory Importer
  • RA Consulting
  • EUDAMED Registration