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
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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November 27, 2020 at 7:56 pm
My query is how the new EUDAMED changes is going to impact the MIR report and flow.
Is SRN going to be mandatory in the MIR?
My undesrstanding is that on Dec-1st-2020 the actor registration module is going to be implemented.Is it correct?
December 21, 2020 at 10:07 pm
Eudamed will implement different modules including market surveillance and vigilance. The goal is to streamline compliance and traceability. Being able to distinguish between good performing devices and bad ones adding additional transparency and finally enhance safety. The actor registration module is indeed up and running.. feel free to write to firstname.lastname@example.org for specific guidance or support
Here more information https://alysidia.com/2020/12/07/first-module-going-live-with-actors-registration-eudamed/