{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-20",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-20.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/20",
  "kind": "regulation",
  "number": "20",
  "heading": "Interpretation of Part III",
  "text": "(1) In this Part...—\n“custom-made device” means an active implantable medical device that is—\n(a)manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; and\n(b)intended to be used only for a particular patient; and\n“relevant device” shall be construed in accordance with regulation 21.\n(2) In this Part..., a reference to a numbered ... Annex is to the ... Annex of Directive 90/385 bearing that number.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 20(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 10(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 20(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 10(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/20",
    "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."
}