EUDAMED delayed!

The European Commission officially announced the delay of the EUDAMED database to May 2022:

” 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.”

 

The European Commission also explained that the EUDAMED database shall improve transparency and coordination of information regarding medical devices available on the EU market. It will contain different modules on actors, UDI & devices, notified bodies & certificates, vigilance, clinical investigations and performance studies and market surveillance.

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