Medical devices: The European Commission updates timelines for the implementation of EUDAMED
EUDAMED is a key aspect of the EU regulatory framework for medical devices, aimed at enhancing transparency by providing an overview of all medical devices available in the EU.
The Commission has earlier proposed and advocated for the adoption of new provisions that allow for a gradual roll-out of the EUDAMED database. Unlike the previous provisions, only mandating the use of EUDAMED once all its modules are completed, the new legal regime allows for flexibility by allowing for a modular roll-out once each module has been audited and is functional. Following the adoption by the Parliament and finally the Council, the revised provisions were formally published in the in the EU's Official Journal on the 9 July 2024.
With the legal framework now allowing for a gradual roll-out, the Commission has updated its timetables indicating when the individual modules become mandatory:
- Notice in the Official Journal for (1) the Actor registration module, (2) the UDI/Devices registration module, (3) the Notified Bodies & Certificates module and (4) the Market Surveillance (MSU) module is expected in July 2025. Their mandatory use is expected six months later, i.e., from January 2026.
- Notice in the Official Journal of the Vigilance module is expected in January 2026 with its mandatory use expectedly starting from July 2026.
- The end of the transition period for the UDI/Device registration module is expected by July 2026 (relevant for legacy devices and MDR devices that continue to be marketed following the mandatory use of the UDI/Devices registration module)
The Commission is expected to soon be publishing a Q&A on the gradual roll-out of EUDAMED. So, keep an eye for the new Q&A which will be published here
See the current timelines for the implementation of EUDAMED
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