Articles 31 of the Medical Device Regulation and Article 28 of the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) require all manufacturers, authorised representatives, and importers to register as actors on the EUDAMED database. The EUDAMED database is set by the European Commission at EU level and is one of the new requirements under the MD and IVD Regulations. The actor registration is not yet mandatory but necessary when applying to a notified body for a conformity assessment procedure.
How is the Actor Registration in EUDAMED performed?
In order to register as an actor, you need to create an account in the EUDAMED database and fill in information regarding:
- Actor identification
- Authorise Representative information (if non-EU manufacturer)
- Actor address
- Contact details
- PRRC details
The authorised representative of non-EU manufacturers must approve their actor registration before submitting it to the Competent Authorities. Once the actor registration is submitted to the Competent Authorities, they will issue a Single Registration Number (SRN) for the manufacturer. This identifier identifies the economic operator in the database.
What information do I need to submit as manufacturer?
On each relevant section, manufacturers should submit the following information:
- Section 1: Actor identification:
- An organisation identification document should be uploaded. This can be your company’s Statute, Notary Act, or Registration document your Competent Authorities;
- Section 2: Authorised Representative:
- The MDR/IVDR Mandate issued by your authorised representative should be uploaded. If this document has not been obtained yet Obelis will provide you with an EAR Certificate for the registration purpose. The use of the EAR Certificate in EUDAMED is temporary and shall be updated with the MDR/IVDR Mandate at the end of the compliance procedure.
- Section 6: Registering Local Actor Administrator:
- A special declaration provided by the European Commission should be filled in and submitted.
Having an authorised representative is key to register as an actor and have your devices compliant with the Regulations. Obelis can help you!
Pablo de Mingo Monge
Publications department
25.08.2023
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