The Medical Devices Regulations 2002

Scope of these Regulations

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(1), as amended(2); 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(3), as amended(4).

(1)

OJ No. L 262, 27.9.1976, p.169.

(2)

Council 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).

(3)

OJ No. L 399, 30.12.1989, p.18.

(4)

Council 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).