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The Human Tissue (Quality and Safety for Human Application) Regulations 2007

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2.—(1) These Regulations extend to England and Wales and Northern Ireland.

(2) Parts 1 to 5 and 7 of, and the Schedules to, these Regulations also extend to Scotland.

(3) These Regulations shall not apply in relation to the processing, preservation, storage, distribution, [F1[F2import from third countries] and export from the United Kingdom] of tissue or cells for use in manufactured products, including medical devices, to the extent that such activities are regulated by—

F3(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F4(b)the Human Medicines Regulations 2012;]

(c)the Medical Devices Regulations 2002, F5...

(d)the Medicines for Human Use (Clinical Trials) Regulations 2004 [F6, F7...

(e)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] [F8, or

(f)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) Paragraph (3) does not limit the application of the amendments made by Part 6 of these Regulations.

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