Actor registration
Published:
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Updated:
Changes
- : Structural changes, Eudamed being mandatory
The first four modules of EUDAMED are now operational and mandatory to use. This means that manufacturers, authorized representatives, importers, and system and procedure pack assemblers must register in the actor registration module.
The following actors are required to register in EUDAMED:
- Manufacturers
- Authorized representatives
- Importers
- System and procedure pack assemblers
The same company could have multiple of these roles, and must then register multiple times. Once registered, they will be assigned an SRN.
Manufacturers of custom-made devices are not required to register in EUDAMED, but they must still report serious adverse events and corrective safety actions via the Vigilance module. To do this, they must, for practical reasons, have registered their organization in EUDAMED. NOMA therefore recommends that manufacturers of custom-made devices also register in the actor module. The Vigilance module is expected to be ready for use in Q2 or Q3 of 2027.
Healthcare institutions that produce medical devices for internal use in accordance with Article 5(5) of MDR/IVDR are not required to register in EUDAMED.
Sponsors of clinical trials must register in the clinical trial and performance study module when it becomes mandatory to use. Currently, we do not know when this will happen, but we will provide updates in newsletters and on our website as information becomes available.
Distributors are also not required to register in EUDAMED.