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EUDAMED IMPLEMENTATION TIMELINE

September 14, 20200

EUDAMED IMPLEMENTATION TIMELINE

 

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives (Eudamed2).

STRUCTURE – EUDAMED MODULES

EUDAMED is structured around 6 interconnected modules and a public website:

  • Actors registration
  • UDI/Devices registration
  • Notified Bodies and Certificates
  • Clinical Investigations and performance studies
  • Vigilance and post-market surveillance
  • Market Surveillance

TIMELINE DELAY

Considering the contingent situation the implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year with respect to the original plan.

Current Plan

  • The Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional
  • The module on Actor registration will be the first module made available. Deployment of the module is planned for December 2020
  • The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021.
  • Afterward, the remaining modules will be displayed as soon as they are functional

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[Source https://ec.europa.eu/]

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