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 diagnosis 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).
EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market.
The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and will be interoperable.
EUDAMED is structured around 6 interconnected modules and a public website:
Actors Registration – to identify all economic operators
Unique Device Identification/Devices registration – to register product specific information
Notified Bodies and Certificates – to form a database of EU certificates
Clinical Investigations and performance studies – to provide collection and analysis of clinical data
Vigilance and post-market surveillance – for Incident reporting
Market Surveillance – Publication of post-market reports from the Competent Authority
The development and implementation of EUDAMED is a high priority for the Commission
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 is available since 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. Afterwards, the remaining modules will be displayed as soon as they are functional.
Source: European Commission
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