Aug 26, 2020

The European Medical Device Coordinating Group (MDCG) has set a deployment date for an important component of the Eudamed database for registration of economic operators.

According to a recent position paper, MDCG plans a December 1, 2020 deadline for rolling out the “actor registration module” of Eudamed. This model entails an electronic system through which economic operator such as medical device manufacturers, Authorized Representatives and importers may request single registration numbers (SRNs) from European Member States.

“The SRN will be needed for declarations of conformity and certificates, and therefore the availability of SRNs is considered very important for the proper functioning of the MDR,” wrote Ronald Boumans, Senior Consultant, Regulatory Affairs at Emergo by UL in a May 2020 analysis of Eudamed implementation timeframes.

The December deployment of the actor registration module accords with the MDCG’s plan for phased implementation of Eudamed database components, originally announced in May 2020.

Additional European MDR and Eudamed resources from Emergo by UL:

Author

  • Stewart Eisenhart

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