EUDAMED (European Databank On Medical Devices)
EUDAMED is the IT system that will be made of 6 modules, established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED is integral part of the implementation of the two Medical Devices Regulations.
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
Currently only the Actor, the UDI/Device and the Notified Bodies and Certificates modules are available. In the future, when all modules will be released and mandatory to use all functionalities shown in the videos will be available.
The Commission implementing Regulation (EU) 2021/2078 of 26 November 2021 lays down the detailed arrangements necessary for the setting up and maintenance of EUDAMED.
The EUDAMED audit has now been completed for the following modules:
Actor Registration
UDI/Product Registration
Notified Bodies and Certificates
Market Surveillance
The remaining modules (Vigilance and Clinical Investigation & Performance Studies) are under development and will be released when they are declared functional and become mandatory to use.