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