# The Medical Devices Regulations 2002, Regulation 3: Scope of these Regulations

Extent: E+W+S

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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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/3 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.