Designation of the competent authority and scope of the Regulations2
1
The Secretary of State is designated the competent authority for the purpose of the Directive.
2
Subject to the following paragraphs, the requirements of these Regulations apply to the collection and testing of blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when they are intended to be used for transfusion.
3
These Regulations apply without prejudice to the Medical Devices Regulations 2002 M1.
4
These Regulations do not apply to blood stem cells.