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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article 30 CELEX: 02017R0746-20250110 European database on medical devices
1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745. 2. Eudamed shall include the following electronic systems: (a) the electronic system for registration of devices referred to in Article 26; (b) the UDI database referred to in Article 25; (c) the electronic system on registration of economic operators referred to in Article 27; (d) the electronic system on notified bodies and on certificates referred to in Article 52; (e) the electronic system on performance studies referred to in Article 69, (f) the electronic system on vigilance and post-market surveillance referred to in Article 87; (g) the electronic system on market surveillance referred to in Article 95. |