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The Blood Safety and Quality Regulations 2005
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- 2005 No. 50
- Regulation 2
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[F1Designation of the competent authority for Northern Ireland and scope of the Regulations]U.K.
This section has no associated Explanatory Memorandum
2.—[F2(1) The Secretary of State is designated the competent authority in relation to Northern Ireland for the purposes 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.
[F3(3) These Regulations apply without prejudice to—
(a)the Medical Devices Regulations 2002,
(b)Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, and
(c)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.]
(4) These Regulations do not apply to blood stem cells.
Textual Amendments
F1Reg. 2 heading substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), reg. 5(a) (as substituted by S.I. 2020/1304, regs. 1, 5); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 2(1) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), reg. 5(b) (as substituted by S.I. 2020/1304, regs. 1, 5); 2020 c. 1, Sch. 5 para. 1(1)
F3Reg. 2(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 20
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