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Registration of economic operator in EUDAMED

The market authorisation of medical devices (MDR, EU/745) and medical devices for in vitro diagnostics (IVDR, EU/746) requires registration. As of January 2026 (expected date), economic operators will be required to register in the European database EUDAMED for this purpose (MDR, Article 31; IVDR, Article 28).

In order to gain access to EUDAMED, manufacturers, importers and authorised representatives can register in the EUDAMED actor registration module, after which they are issued with a single registration number, or SRN. This SRN number allows access to EUDAMED and makes it possible, for example:

  • to request a conformity assessment from a notified body;
  • to submit the obligatory product information about medical devices or in vitro diagnostic medical devices;
  • to submit obligatory reports of incidents or corrective actions involving medical devices or in vitro diagnostic medical devices.

Competent authority

In the Netherlands, the Central Information Point for Healthcare professions (CIBG) is the competent authority for the registration of economic operators in the EUDAMED actor registration module. The CIBG is also responsible for issuing export certificates (market access for countries outside the EU) to manufacturers registered in the Netherlands. It assesses all new applications and, if approved, grants access to economic operators. If the details are complete and verified, the registered users will receive an SRN.

Registration via SRN

After completing the actor registration Farmatec assesses your application for uniqueness (double applications), completeness and registered address in the Netherlands. In the event of a positive assessment, the SRN is assigned.
For the registration process and supplementary information, please visit the CIBG website (in Dutch).

More information

More information on the future developments of EUDAMED, registration and the issuing of the SRN can be found on the following websites: