- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (01/04/2009)
- Gwreiddiol (a wnaed Fel)
Version Superseded: 21/03/2010
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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 26 August 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 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 [F1—
(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[F2, except for active implantable medical devices, in vitro diagnostic medical devices and accessories to such devices];
[F3(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 an active implantable medical device or an in vitro diagnostic medical device, or an accessory to such a device;]
(f)cosmetic products governed by Council Directive 76/768/EEC M1, as amended M2; or
(g)products whose principal intended purpose is such that they fall under Council Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment M3, as amended M4.
Textual Amendments
F1Words in reg. 3(c) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(a)
F2Words in reg. 3(d) inserted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(b)
F3Reg. 3(e) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(c)
Marginal Citations
M1OJ No. L 262, 27.9.1976, p.169.
M2Council 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).
M3OJ No. L 399, 30.12.1989, p.18.
M4Council Directive 89/686/EEC has been amended by Council Directive 93/68/EEC (OJ No. L 220, 30.8.1993, p.1), Council Directive 93/95/EEC (OJ No. L 276, 9.11.1993, p.11) and Council Directive 96/58/EC (OJ No. L 236, 18.9.1996, p.44).
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