Scope
Article 1
1. This Directive shall apply to the import into the Union of: (a) human tissues and cells intended for human application; and (b) manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other Union legislation. 2. Where the human tissues and cells to be imported are intended to be used exclusively in manufactured products which are covered by other Union legislation, this Directive shall only apply to the donation, procurement and testing which takes place outside of the Union as well as to contributing to ensuring traceability from donor to recipient and vice versa. 3. This Directive shall not apply to: (a) the import of tissues and cells referred to in Article 9(3)(a) of Directive 2004/23/EC which are directly authorised by the competent authority or authorities; (b) the import of tissues and cells referred to in Article 9(3)(b) of Directive 2004/23/EC which are directly authorised in case of emergencies; (c) blood and blood components as defined by Directive 2002/98/EC; (d) organs or parts of organs, as defined in Directive 2004/23/EC.