What is EUDAMED?
EUDAMED is the IT system developed by the European Commission. The main objective of EUDAMED is to implement the following EU medical device regulations:- Regulation 2017/745 on Medical Devices
- Regulation 2014/746 on invitro Diagnostic Devices
- 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
In this slide deck we look at:
- Why it was time to move from the Medical Devices Directive (MDD) to the new Medical Devices Regulations (MDR)
- What significant changes are contained in the MDR
- The do’s and don’ts for each step of the EUDAMED Registration process