Delay to the EUDAMED release

Usually well informed sources shared today the news, that the EU Commission today mentioned a two year delay to the EUDAMED release. They are working on further definition of transitional measured for the MDR and IVDR implementation.

Please find below the official announcement from the European Commission of the EUDAMED release delay:

“The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.”

The complete announcement can be found here.