The development of the Eudamed database reached a major milestone

Posted on 03.07.2018

The development of the European database on medical devices (‘Eudamed’) reached a major milestone on 26 May 2018 to meet the legal requirements as per Article 34 of the Medical Device Regulation 2017/745/EU. The Eudamed IT team of DG GROW has compiled the Eudamed implementation plan and the draft Functional Specifications for all electronic systems/modules (on registration of UDI & devices, on registration of economic operators, on certificates, on clinical investigations/performance studies, on vigilance & post-market surveillance and on market surveillance). IT engineering details, such as process overviews, data models and business rules are aimed to be ready in October 2018.

The expected finalization of all modules for the external audit is by September 2019 that is necessary for meeting the target date on 25 March 2020 for the first release of Eudamed.