It is specifically intended to move from MDR reasons to a new recording system with EUDAMED to ensure transparency for Medical Device manufacturers and all industry stakeholders. Medical Device manufacturers;

  • EUDAMED must be registered within 18 months if EUDAMED is fully functional prior to the MDR implementation date.
  • Otherwise, it is expected that a statement will be published in the Official Journal of the European Union stating that the EUDAMED database is fully functional.
  • MDD certified devices are expected to be registered within 24 months after the notification date, or
  • In case of serious adverse event or field safety corrective action after the notification, the registration of the devices that continue to be placed on the market at the time of serious adverse event/field safety corrective action reporting should be performed.

 

Note: All Medical devices with MDD documentation should only be registered to the EUDAMED database without Basic UDI-DI and UDI-DI if a serious adverse event report and/or field safety corrective activity report (with site safety notification) appears after the date of the application.

 

EUDAMED MODULES

  • Actor registration
  • UDI/Device records
  • Notified Body and Certifications
  • Clinical research and Performance studies
  • Vigilance and Post-Marketing Surveillance
  • Market Surveillance

 

https://ec.europa.eu/tools/eudamed/#/screen/home