Guide to Using EUDAMED
Actor registration module for economic operators
Version 0.1 – September 2020
EUDAMED is the IT system developed by the European Commission to implement the EU medical devices regulations:
- Regulation 2017/745 on medical devices
- Regulation 2017/746 on in vitro diagnosis devices
EUDAMED is structured around 6 interconnected modules and a public site:
- 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