# The Medical Devices Regulations 2002, Regulation 5: Interpretation of Part II

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

(1) In this Part ...—
“accessory” means an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer;
“custom-made device” means a relevant device that is—
(a)manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification, which gives, under his responsibility, specific characteristics as to its design; and
(b)intended for the sole use of a particular patient,
but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;
“relevant device” shall be construed in accordance with regulation 6;
“single-use combination product” means a product which comprises a medical device and medicinal product forming a single integral product which is intended exclusively for use in the given combination and which is not reusable; and
“system or procedure pack” has the same meaning as in article 12 of Directive 93/42.
(2) In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.

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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/5 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.