The module on Actor registration is the first module made available to Member States and economic operators from 1 December 2020 by The European Commission. Every economic operator has to register as an actor in EUDAMED.
Actors involved in EUDAMED are:
- Supervising Bodies
- European Commission (EC)
- Competent Authorities (CAs), including Designating Authorities
- Notified Bodies (NBs)
- Economic Operators
- Manufacturers (EU and non-EU)
- System and Procedure Pack Producers
- Authorised Representatives (ARs)
If you are an economic operator who needs to be officially recognised as an actor in EUDAMED – and therefore as an actor on the EU market with a Single Registration Number (SRN) – you must register your details using the Actors module.
Economic operators (including manufacturers, system/procedure pack producers, AR and importers) established within the EU 27, Iceland, Liechtenstein and Norway will be able to submit actor registration requests in EUDAMED from December 2020.
Non-EU manufacturers will be able to register only if their authorised representative is established within the EU 27, Island, Lichtenstein and Norway. Economic operators from the UK, Switzerland and Turkey will only be able to submit actor registration requests in EUDAMED at a later stage, not from December 2020.
EUDAMED Medical Consultancy is always ready to help you manage EUDAMED Actor Registration processes related to your company.