Global News: EU Delays Launch of Eudamed Database

The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022.  Originally, manufacturers were supposed to be compliant by May 2020 with the new Medical Device and In Vitro Diagnostic Regulations, but technical challenges forced the delay.

According to a statement published online, the EC will continue to work on implementing the database, but 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.” The date of application of the MDR remains May 2020, and medical device manufacturers are expected to collect the necessary data and enter into Eudamed once available.

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