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EU – Official position on EUDAMED 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 date of application of the MDR remains May 2020.

From European database on medical devices (EUDAMED).

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