EUDAMED registration – An overview
EUDAMED is the IT system made of 6 interconnected modules developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
- Actor and user registration and management
- UDI database and registration of devices
- Certificates and Notified Bodies
- Clinical Investigation and performance studies
- Vigilance and post-market surveillance
- Market surveillance
All economic operators are obliged to register. Economic Operators include Medical device Manufacturers, Authorized Representatives, Importers, and System or Procedure Pack Producers. If your company holds more than one of these roles, then registration must be done multiple times to receive SRN for each role.
MDR and IVDR Requirements for completing EUDAMED Registration.
Once Technical File documentation compilation has completed, and E.A.R. had been appointed by Non-EU Manufacturer, Registration Process in Eudamed can be commenced. This process is done before appointing Notified body for the assessment as per conformity assessment procedure for high- risk class medical devices.
- Obtain basic UDI-DI and the UDIs from the Issuing Entities designated by the EU Commission such as IFA GmbH, GS1, Health Industry Business Communications Council (HIBCC), ICCBBA.
- Obtain Single Registration Number by registering as Actor module in EUDAMED.
- once economic operators register themselves in Eudamed and obtain SRN after verification from competent authority, manufacturer should use this SRN for applying to notified body for Conformity assessment.
- For low-risk medical devices and In-Vitro Diagnostic Devices, declaration of conformity serves as purpose of registration but for higher class of medical devices, notified body involvement is required for conformity assessments.
How can we help manufactures with EUDAMED Registration?
- Assist in providing an official European Authorized Representative who is already registered as Actor Module in Eudamed.
- Assist in selecting Competent Authority for both EU manufacturer and Non-EU Manufacturer.
- Assist in selecting Notified body for Conformity Assessment for higher class of medical devices.
- Assist in preparing Declaration of conformity for low risk of medical devices and In-Vitro Devices.