Eudamed: EC posts info on actor registration module
With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. (RELATED: Eudamed actor registration module set to launch in December, Regulatory Focus 19 August 2020).
The EC’s newly posted webpage on the actor registration module provides information on obtaining a single registration number (SRN), the actor registration request process and the process for granting additional users access to an actor’s profile. An infographic is provided for each of the three topics.
The page also explains the documentation required to submit a registration request and provides a user guide for economic operators and technical documentation for the module.
All economic operators, including manufacturers, authorized representatives, system/procedure pack producers and importers, must submit an actor registration request in Eudamed to receive an SRN. The requests will be reviewed by the relevant national competent authority and an SRN will be generated when the request is approved. For non-EU manufacturers, the selected authorized representative must verify the registration request before passing it to the national competent authority for review.
Each economic actor that registers for Eudamed must obtain an SRN for each role they fulfill. For example, a company that manufactures and imports medical devices would need to submit two registration requests and would be assigned two unique SRNs.
To submit an actor registration request, actors must provide a signed declaration on information security responsibilities and non-EU manufacturers must also furnish a mandate summary document.
The infographic on user access requests explains the hierarchy of profiles within Eudamed for the competent authorities and different types of actors. The Commission says that actors must always have at least one active local actor administrator (LAA) for their profile and recommends having at least two LAAs as a failsafe. Below the LAA, the local user administrator (LUA) is tasked with managing user access requests.
EC