Europe – EUDAMED : Draft Functional specifications

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices were published in the OJ on 5 April 2017, entered into force on 25 May 2017 and shall apply from 26 May 2020 and from 26 May 2022 respectively. They will repeal Council Directives 90/385/EEC on active implantable medical devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic medical devices.
Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746 are the main articles requiring the setting up, maintenance and management of the future Eudamed by the Commission, after consulting the Medical Device Coordination Group (MDCG) made of one representative per Member State and chaired by the Commission. These Articles are furthermore associated to almost 50 other articles in each Regulation which means that Eudamed is a keystone for the implementation of the new Regulations, enabling many things, among which devices’ traceability and better health
protection thanks to an effective proactive market surveillance…