# The Medical Devices Regulations 2002, Regulation 20: Interpretation of Part III

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

(1) In this Part...—
“custom-made device” means an active implantable medical device that is—
(a)manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; and
(b)intended to be used only for a particular patient; and
“relevant device” shall be construed in accordance with regulation 21.
(2) In this Part..., a reference to a numbered ... Annex is to the ... Annex of Directive 90/385 bearing that number.

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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/20 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.