EU: EUDAMED launch postponed

According to information on its website, the EU is postponing the launch of the EUDAMED database until May 2022.

Under the "state of play" point, it says:

"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 date of application of the MDR remains May 2020."

This means that Article 123(3d) of the regulation becomes relevant; this lists the articles of the MDR that are affected by this postponement. No further announcements have been made regarding implementation in practice.


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