Oktober 31, 2019
Regulatory Medical Device Regulation

EUDAMED Delay Confirmed

Under the new MDR, medical device manufacturers are obligated to register their products in the European databank for medical devices (EUDAMED). It has now been confirmed by the European Commission that the database will not be ready to launch in time for the new medical device regulation that goes into effect in May 2020.

In an article on the official EUDAMED website, the European Commission disclosed on 25 October that the database will be delayed by two years.

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, states the article.

The European Commission cites that not all modules are ready and the reduction of IT resources as reasons for the delay.

The agency further suggests to affected companies to view this delay positively due to the gain in preparation time.

Or as Richard Houlihan, CEO of Eudamed.eu, puts it:
A very wise man said to me last week "If the EC do delay, I hope companies use the time better than the British did with Brexit."

The date of application of the MDR remains May 2020.


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