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 six interconnected modules and a public site:
• Actor – 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
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