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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART I
- Regulation 3
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Version Superseded: 10/03/2007
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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 04 November 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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Scope of these RegulationsU.K.
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 stable derivatives devices;
(d)transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin;
(e)transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue;
(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.
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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