1.This Directive 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 Articles 5 to 9 of this Directive, 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.