(11)Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council 8 and Directive 2004/23/EC of the European Parliament and of the Council 9 , is incomplete in respect of certain products manufactured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable. Such products should come under the scope of this Regulation, provided they comply with the definition of a medical device or are covered by this Regulation.
Recital 11
- 8 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 ( OJ L 324, 10.12.2007, p. 121 ). ↩
- 9 Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ( OJ L 102, 7.4.2004, p. 48 ). ↩