# The Medical Devices Regulations 2002, Regulation 6: Scope of Part II

Extent: E+W+S+N.I.

The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—
(a) active implantable medical devices and accessories to such devices; and
(b) in vitro diagnostic medical devices and accessories to such devices; and
(c) devices that come within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and
(i) the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and
(ii) the manufacturer chooses to follow the set of arrangements in the other Directive.

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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/6 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.