From 1 December 2020, the European Commission will make available the Actor registration module, which is the first of six EUDAMED modules, to Member States and economic operators.
This new 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.
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. The national competent authority responsible for the authorised representative issues the SRN (generated by EUDAMED) after approving the registration request.
To submit an actor registration request, actors must provide a signed “Declaration on information security responsibilities” and non-EU manufacturers must also submit a “Mandate Summary document”.
The first person who registers an actor in EUDAMED automatically receives a Local Actor Administrator (LAA) profile. This LAA profile is strictly reserved for people who will be responsible for maintaining the actor’s details in EUDAMED and/or validating, updating, or deleting access requests. The European Commission strongly recommend having at least two LAA to act as a fail save mechanism if one should be unable to respond.
What does this mean to you?
The full functionality of EUDAMED, which requires the availability and full operation of all six modules in accordance with the technical specifications and confirmed by an audit as referred to in Article 34 of the MDR, is foreseen for May 2022. Nevertheless, as stated in MDCG 2020-15 , the members of the Medical Device Coordination Group (MDCG) strongly encourage the use of the actor registration module by all relevant actors on their territories, including the use of the single registration number by actors as stipulated in the MDR and IVDR (e.g. indicating the SRN on certificates).
Today, manufacturers and authorized representatives of CE marked medical devices need to notify on a national basis in the EU country where they are established. The members of the MDCG have agreed that double registration requirements for actors should be avoided 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.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.