EUDAMED is the European Database on Medical Devices. With the Medical Devices Regulations (MDR and IVDR), EUDAMED has been introduced to ensure traceability of the devices within the supply chain and strengthen market surveillance and transparency in the European Union.
Registration in EUDAMED is mandatory from the moment the European Commission announces that the database is fully functional and as follows:
- Within 6 months for actor registration
- Within 24 months for device registration
- Immediately in case of incidents
EUDAMED – Who needs to register
Economic operators must register in EUDAMED. Manufacturers, authorised representatives, system and procedure pack producers, and importers must register as actors, both those based in the EU and outside of the EU.
EUDAMED has six different modules:
- Actor registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
SRN numbers, EMDN and Basic UDI-DI
There are several numbers and codes connected with the EUDAMED registration, such as the SRN number, EMDN codes, and Basic UDI-DI.
Most importantly, each actor receives a Single Registration Number (SRN) that is assigned to a specific economic operator. The SRN is issued as soon as the competent authority has accepted the actor registration. Specifically, the SRN is composed by the country code (e.g., “BE” for Belgium), followed by the actor role abbreviation (e.g., “MF” for manufacturer) and by nine digits.
The EMDN (European Medical Device Nomenclature) are codes which group medical devices in in sets of terms, or nomenclature. To register devices in EUDAMED, manufacturers must provide these codes. Finally, Basic UDI-DI are sets of codes which group devices with same intended purpose, risk class, and essential design and manufacturing characteristics. By contrast to the UDI-DI, the Basic UDI-DI does not appear on the labels of the devices. To register devices in EUDAMED, manufacturers must provide the Basic UDI-DI for their devices – except for legacy devices.
How to help manufacturers gathering all necessary information
As your Regulatory Consultancy and Authorised Representative, Obelis helps manufacturers of medical devices and IVDs:
- Validate your actor registration to obtain the SRN number
- Research the correct EMDN codes for your devices
- Verify your device registration in EUDAMED
- Access the EU, UK, and CH market, acting as your authorised representative
Contact us today to know more about how to approach the European market!