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).