CHAPTER I

GENERAL PROVISIONS

Scope
Article 2
1
This Directive shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion.
2
Where blood and blood components are collected and tested for the sole purpose and exclusive use in autologous transfusion and are clearly identified as such, the requirements to be complied with in respect thereof shall be in accordance with those referred to in Article 29(g).
3
This Directive shall apply without prejudice to Directives 93/42/EEC , 95/46/EC or 98/79/EC .
4
This Directive does not apply to blood stem cells.
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). Directive as last amended by Directive 2001/104/EC of the European Parliament and of the Council (OJ L 6, 10.1.2002, p. 50).
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).