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The Medical Devices Regulations 2002, Section 3 is up to date with all changes known to be in force on or before 11 September 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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3. 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). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Words 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)
F2Words 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)
F3Words in reg. 3(c) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(a)
F4Words in reg. 3(d) inserted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(b)
F5Words 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)
F6Words in reg. 3(d) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(b)
F7Reg. 3(e) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(c)
F8Words 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)
F9Words 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)
F10Reg. 3(g) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(d)
3. These Regulations shall not apply to—
(a)medicinal products governed by Directive 2001/83 (including medicinal products derived from human blood or human plasma governed by Title X of Directive 2001/83);
(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 [F11—
(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 [F12, except for F13..., in vitro diagnostic medical devices and accessories to such devices] [F14save where medicinal products are incorporated as ancillary to the device];
[F15(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 F16... an in vitro diagnostic medical device, or an accessory to such a device;]
(f)cosmetic products governed by Council Directive 76/768/EEC F17, as amended F18; or
F19(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F11Words in reg. 3(c) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(a)
F12Words in reg. 3(d) inserted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(b)
F13Words 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)
F14Words in reg. 3(d) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(b)
F15Reg. 3(e) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(c)
F16Words 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)
F17OJ No. L 262, 27.9.1976, p.169.
F18Council Directive 76/768/EEC was amended for the twenty-sixth time by Commission Directive 2000/41/EC (OJ No. L 145, 20.6.2000, p.25).
F19Reg. 3(g) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(d)
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