Hamburg, 19 August 2020, Christoph Petershagen/i>
The Medical Device Coordination Group (MDCG) has release a new guidance document with the title “Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States” (MDCG 2020-15). Within this paper the MDCG describes that, even though the official date of release for EUDAMED will stay at May 2022, the module for registration of economic operators will be available for the competent authorities of the member states by 01 December 2020.
With this it should be possible to register and generate a SRN for every manufacturer, authorized representative, importer and/or producer of systems/procedure packs by December 2020. This is especially important, since this number is mandatory for many documents, like for example the declaration of conformity. However, the date from which the competent authorities will be able to use this system effectively is still unclear. In addition, the aim of this paper is that competent authorities issue the registration exclusively in EUDAMED to prevent double registrations (EUDAMED and national registration).