The EU EC have just released a new revision of the EUDAMED Economic Operator user guide, v2.7.
How economic operators can use the actor registration module – concept, registration, management, access and mandates.
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