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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ) article 25 CELEX: 02017R0745-20250110 Identification within the supply chain
1. Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. 2. Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8): (a) any economic operator to whom they have directly supplied a device; (b) any economic operator who has directly supplied them with a device; (c) any health institution or healthcare professional to which they have directly supplied a device. |