EUDAMED
EUDAMED Support for Non-EU Medical Device Manufacturers
Structured preparation of manufacturer, mandate and device data for European regulatory registration workflows.
Structured regulatory data
EUDAMED requires economic operators to maintain consistent legal, regulatory and device-identification information.
Actor registration and SRN
We support preparation of the information needed for economic-operator registration and Single Registration Number workflows.
Typical preparation areas
- Manufacturer legal identity.
- Authorised Representative information.
- Mandate information.
- Actor ID / SRN status.
- Basic UDI-DI.
- UDI and device information.
- Classification and nomenclature data.