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The Medical Devices Regulations 2002, Section 5 is up to date with all changes known to be in force on or before 23 July 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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5.—(1) In this Part F1...—
“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—
manufactured specifically in accordance with a written prescription of a [F2registered 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
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 F1..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.
Textual Amendments
F1Words in reg. 5(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 4
F2Words in reg. 5(1) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 4
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