Registration of economic operator in EUDAMED
The new regulations for the market authorisation of medical devices (MDR, EU/745) and in vitro diagnostic medical devices (IVDR, EU/746) imply certain changes. One important change for both economic operators and the EU member states is the obligation to register information centrally in the European EUDAMED database (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
The CIBG is the competent authority for the Netherlands as regards the registration of economic operators in the EUDAMED actor registration module. 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:
• EUDAMED user documentation: User Guide for Economic Operators (pdf)
• All European Commission (technical) information on EUDAMED
• More information on the obligations of economic operators in EUDAMED: Central government website