Eudamed is an IT system developed by the EC to implement medical device and in vitro diagnostic (IVD) medical device regulation (EU Regulation 2017/745 and EU Regulation 2017/746, respectively).
The purpose of Eudamed is to improve transparency and coordination regarding medical devices available on the EU market. It will function as a registration system, notification system, and a system for collaboration and dissemination of information to the public. The Eudamed modules will include actor and device registration, notified bodies and certificates, clinical investigations and performance studies, as well as vigilance and post-market surveillance.
When will Eudamed be fully functional?
Eudamed is planned to be fully functional in May 2022.
What type of medical device information will be available to the public?
See the Fact sheet on MDR requirements for transparency and public information.
EUDAMED Overview: https://ec.europa.eu/health/md_eudamed/overview_en, Accessed 24 August 2020.
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