Actor Registration
The Actor Registration Module is the first publicly accessible part of EUDAMED, the European database for medical devices. Before engaging with the system, every individual or organization—referred to as an ‘actor’—must register here. According to the EU, an actor is any natural person or legal entity with a defined role that must be recorded in EUDAMED.
There are seven distinct actor roles, each with specific duties. These roles fall into two main categories:
Supervisory Actors:
- European Commission
- National competent and designated authorities
- Notified bodies
Economic Operators:
- Manufacturers
- Authorized representatives
- System and procedure pack producers
- Importers
Economic operators are issued a Single Registration Number (SRN) once their registration is validated by a competent authority. This SRN uniquely identifies them within EUDAMED.
Roles Explained
European Commission
As the creator of EUDAMED under the MDR and IVDR regulations, the European Commission plays an administrative role. While its specific tasks aren’t detailed in the legislation, it likely manages access rights and oversees the system’s functionality.
Competent and Designated Authorities
These authorities are responsible for reviewing and approving economic operators’ registrations and issuing SRNs. Designated authorities also oversee notified bodies, approve them, and ensure their compliance by recording relevant data in EUDAMED.
Notified Bodies
These are typically private organizations that assess and certify medical devices before they enter the EU market. They also monitor devices after approval. Their role in EUDAMED includes recording the outcomes of product evaluations—whether approved, rejected, or withdrawn. Their credentials are listed in the NANDO database.
Economic Operators
Manufacturers, System and Procedure Pack Producers
These actors must register their organization and products in EUDAMED, including assigning a Basic UDI-DI (Unique Device Identifier – Device Identifier) to each product.
Authorized Representatives
They act on behalf of manufacturers based outside the EU, handling registration and product maintenance in EUDAMED.
Importers
Importers must ensure that the products they bring into the EU are registered in EUDAMED. Within two weeks of placing a device on the market, they must verify that the manufacturer or authorized representative has entered the necessary data. If not, they are required to notify the responsible party.
Shared Responsibilities
- All actor roles are expected to:
- Conduct post-market surveillance
- Register clinical investigations
- Report incidents and safety alerts
- Keep product and organizational data up to date in EUDAMED
EUDAMED Medical Consultancy is always ready to help you manage EUDAMED Actor Registration processes related to your company.