With the introduction of the new Medical Device Regulations (MDR) in May 2021, we have noticed many new processes and systems being introduced. One of these has been the registration of all Medical Device Manufacturers in a totally new system called EUDAMED.
We have prepared a short guide to help you navigate the complexities of EUDAMED. One of our Senior MDR Regulatory Affairs Consultants, Michelle Greaney, has created a slide deck that takes you through the Do’s and Don’ts for a successful EUDAMED registration.
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
EUDAMED consists of 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
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
