Regulation 3 Scope of these RegulationsE1

England, Wales and Scotland

These Regulations shall not apply to—

(a)

medicinal products governed by F1the Human Medicines Regulations 2012 (including medicinal products derived from human blood or human plasma F2...);

(b)

human blood, human blood products, plasma or blood cells of human origin;

(c)

devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for F3—

(i)

stable derivatives devices,

(ii)

active implantable medical devices and accessories to such devices, and

(iii)

in vitro diagnostic medical devices and accessories to such devices,;

(d)

transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin F4, except for F5..., in vitro diagnostic medical devices and accessories to such devices F6save where medicinal products are incorporated as ancillary to the device;

F7(e)

transplants or tissues or cells of animal origin, unless—

(i)

a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

(ii)

a product is F8... an in vitro diagnostic medical device, or an accessory to such a device;

(f)

cosmetic products governed by F9Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products; or

F10(g)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1: Words in reg. 3(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(5)(c)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 3(a) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(5)(c)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in reg. 3(c) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(a)
F4: Words in reg. 3(d) inserted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(b)
F5: Words in reg. 3(d) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(a)
F6: Words in reg. 3(d) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(b)
F7: Reg. 3(e) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(c)
F8: Words in reg. 3(e)(ii) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(c)
F9: Words in reg. 3(f) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(5)(d) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F10: Reg. 3(g) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(d)

Extent

E1: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only