New MDCG Position Paper on EUDAMED actor registration module and SRN released

On 18.08.2020, the MDCG published a Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN).

Following the decision of 12 March 2020, through which the MDCG agreed that the European Commission makes available to Member States each EUDAMED module gradually as soon as operational, the European Commission confirmed its readiness to deploy the actor registration module as of 1 December 2020.

The MDCG strongly encourages the use of the actor registration module and the single registration number by all relevant actors on their territories (e.g. indicating the SRN on certificates), and warn against double registration requirements for actors as much as possible:

”Therefore, actors that obtain an SRN should be considered in compliance with the actor registration requirements (for manufacturers, authorised representatives, importers, system/procedure pack producers) to the extent that national laws accommodate for this. In such cases, those actors should follow the obligations and requirements of the MDR related to both the registration of relevant actors (via the actor registration module) and the use of their SRN as required. ”

The full text of the Position Paper is available at this link and on our Library of Documents – icons MDCG and Position Papers.




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