From today EUDAMED (European Database on Medical Devices) is open for Actor registration to obtain a single registration number (SRN).
This is the first of 6 modules.
Every economic operator – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information:
- Information about the actor (manufacturer/importer/AR/system & procedure pack producer)
- Declaration on information security responsibilities (template published)
- Mandate Summary document (for non-EU manufacturers)
- At least 1 PRRC
For more information: https://ec.europa.eu/health/md_eudamed/actors_registration_en