EUDAMED IMPLEMENTATION TIMELINE
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
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.
- 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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