EUDAMED (European Databank On Medical Devices)
EUDAMED is the IT system that will be made of 6 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.
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
The European Commission is made available the Actor Registration Module to Member States and economic operators on December 1, 2020.
The module on UDI database & device registration (second module) and the module on Certificates and Notified Bodies (third module) are available since October 2021, except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. Afterwards, the remaining modules as well as the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.