Page Last Updated: 7 September 2023
Company registrations are submitted in the EUDAMED Actor Registration Module. Once the Actor registration is approved, companies are issued a unique Single Registration Number (SRN).
What is an Actor?
Simply put, an Actor is any organization that is required to register in EUDAMED.
Actors include Supervising Entities (e.g., European Competent Authorities), in addition to Economic Operators.
Per the EU Commission’s document on Actor Roles:
“An actor is a natural or legal person (organisation) with a specific role that has to be registered in EUDAMED.”
Which Economic Operators have to register in EUDAMED?
The following Economic Operators must register in EUDAMED as Actors:
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- Manufacturers (both EU and non-EU)
- System/procedure pack producers
- Authorised Representatives
- Importers
While distributors are also Economic Operators and must meet certain obligations under the MDR/IVDR, they will not register in EUDAMED.