S.L. 483.4 Art. 2Objective.

(1) These regulations shall apply to the coding, processing, preservation, storage and distribution of:

(a) human tissues and cells intended for human applications; and

(b) manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other directives.

(2) The provisions of regulations 6 to 9 of these regulations, concerning traceability and the reporting of serious adverse reactions and events shall also apply to the donation, procurement and testing of human tissues and cells.

(3) These regulations shall not apply to:

(a) tissues and cells used as an autologous graft within the same surgical procedure;

(b) blood and blood components as defined by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing,

*see regulation 1(3) of these Regulations, as originally promulgated. processing, storage and distribution of human blood and blood components and amending Directive 2001/ 83/EC;

(c) organs or parts of organs if it is their function to be used for the same purpose as the entire organ in the human body.