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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 reg 3

reg 3 Scope of these Regulations

These Regulations shall not apply to— (a) medicinal products governed by the Human Medicines Regulations 2012 (including medicinal products derived from human blood or human plasma ...); (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 — (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 , except for ..., in vitro diagnostic medical devices and accessories to such devices save where medicinal products are incorporated as ancillary to the device ; (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 in vitro diagnostic medical device, or an accessory to such a device; (f) cosmetic products governed by Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products; or (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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