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No Eudamed, No Problem! Latest Guidance Explains Alternatives While Database Is Built

 
• By Amanda Maxwell

Lack of an official explanation about how the exchange of critical information will progress pending the launch of the EU’s medical device database, Eudamed3, has left many confused. New guidance lights the way forward.

Traffic lights

Clarification about how the various actors, manufacturers, notified bodies and competent authorities should exchange information in the context of the Medical Device Regulation, pending the official launch of the new version of the Eudamed database, is now available. The Medical Device Coordination Group (MDCG) has endorsed a 31-page guidance on harmonized administrative practices and alternative technical solutions (MDCG 2021-1).

Eudamed Timeframe

Eudamed provides the framework to enable the much-demanded transparency in the new regulatory system. It cannot fully apply until all six inter-related modules are ready.

It was originally foreseen that it would be up and running May 2020. But now, it is not due to be officially launched until 26 May 2022, the date of the full application of the IVD Regulation, and exactly one year after the delayed MDR fully applies.

Even after launch, there is a transition period allowing actors in the sector another six months after publication of the notice in the Official Journal of the EU declaring the database fully functional until they need to fully comply. (Requirements set out in MDR Articles 29(4) relating to the registration of devices, and Article 56(5) relating to notified body certificates will fully apply 24 months after the notice

The guidance explains how the medtech sector can best comply with exchange MDR-related information in the areas of device registration, clinical investigation and vigilance, for example, in the absence of the full Eudamed database

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