{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-5",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-5.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/5",
  "kind": "regulation",
  "number": "5",
  "heading": "Interpretation of Part II",
  "text": "(1) In this Part ...—\n“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;\n“custom-made device” means a relevant device that is—\n(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\n(b)intended for the sole use of a particular patient,\nbut does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;\n“relevant device” shall be construed in accordance with regulation 6;\n“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\n“system or procedure pack” has the same meaning as in article 12 of Directive 93/42.\n(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.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words 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"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 5(1) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 4"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/5",
    "retrieved_at": "2026-10-29T07:11:50.089580+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}