{
  "url": "https://openlegislation.uk/medical-devices-regulations-1994/regulation-3",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-1994/regulation-3.json",
  "legislation": "uksi/1994/3017",
  "legislation_title": "The Medical Devices Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-1994",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Application of Regulations",
  "text": "(1) Subject to paragraph (2), these Regulations shall apply to medical devices and their accessories and, for the purposes of these Regulations, accessories shall be treated as devices in their own right.\n(2) These Regulations shall not apply to—\n(a) devices used for in vitro diagnosis;\n(b) active implantable devices covered by Council Directive 90/385/EEC as amended by the Directive and by Council Directive 93/68/EEC;\n(c) medicinal products covered by Council Directive 65/65/EEC as last amended by Council Directive 93/39/EEC;\n(d) cosmetic products covered by Council Directive 76/768/EEC as last amended by Council Directive 93/47/EEC;\n(e) human blood, human blood products, human plasma or blood cells of human origin or devices which incorporate at the time of placing on the market such blood products, plasma or cells;\n(f) transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin;\n(g) transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue; or\n(h) products whose principal intended purpose is such that they fall under Council Directive 89/686/EEC as amended by Council Directive 93/68/EEC.\n(3) Except for the purposes of regulation 5(2), these Regulations shall not apply to devices intended to administer a medicinal product within the meaning of Article 1 of Council Directive 65/65/EEC where the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable.\n(4) References in subsequent provisions of these Regulations to devices are references to devices to which these Regulations apply in accordance with the preceding paragraphs of this regulation.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L 189, 20.7.90, p. 17."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L 220, 30.8.93, p. 1."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ No. L 214, 24.8.93, p. 22."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ No. L 262, 27.9.76, p. 169."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "OJ No. L 203, 13.8.93, p. 24."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "OJ No. L 399, 30.12.89, p. 18."
    }
  ],
  "outstanding_effects": [
    {
      "type": "substituted",
      "affecting": "uksi/2000/1315",
      "affecting_title": "The In Vitro Diagnostic Medical Devices Regulations 2000"
    },
    {
      "type": "amended",
      "affecting": "uksi/2000/1315",
      "affecting_title": "The In Vitro Diagnostic Medical Devices Regulations 2000"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3017/regulation/3",
    "retrieved_at": "2026-10-29T13:22:16.279438+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."
}