Author: Dr. Suzanne Broussard
One of the recent announcements in the everchanging medtech sector is that the newest European database on medical devices (Eudamed 3) will roll out modules as they become functional. Eudamed 3 is the cornerstone for the new medical device regulations (MDR) and in vitro device regulations (IVDR) and is by all accounts an ambitious project.
The version of Eudamed currently in use (Eudamed2) is a secure web-based portal designed to conduct effective market surveillance on medical devices through information exchange between competent Authorities and the Commission.
Eudamed 3 will be dramatically different when it eventually rolls out. Eudamed 3 is designed to be multipurpose and function as a:
- Registration system
- Collaborative system
- Notification system
- Dissemination system (open to the public)
The original intention was that the newest Eudamed database would launch at the same time as the original MDR date of application. However, challenges in preparing the new updated system forced the delay by 2 years. Under this delay, Eudamed 3 will roll out on 26 May 2022.