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EUDAMED Actor registration module available from December 1st

December 1, 2020

From today EUDAMED (European Database on Medical Devices) is open for Actor registration to obtain a single registration number (SRN).

This is the first of 6 modules.

Every economic operator – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information:

  1. Information about the actor (manufacturer/importer/AR/system & procedure pack producer)
  2. Declaration on information security responsibilities (template published)
  3. Mandate Summary document (for non-EU manufacturers)
  4. At least 1 PRRC

 

For more information: https://ec.europa.eu/health/md_eudamed/actors_registration_en

 

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