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Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) article 6 CELEX: 02007R1394-20190726 Issues specific to medical devices
1. A medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex I to Directive 93/42/EEC. 2. An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex 1 to Directive 90/385/EEC. |