{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002.json",
  "id": "uksi/2002/618",
  "title": "The Medical Devices Regulations 2002",
  "short_title": "Medical Devices 2002",
  "long_title": "These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93/42/EEC concerning medical devices, as amended; and Directive 98/79/EC of the European Parliament and of the Council onin vitro diagnostic medical devices (“the Medical Devices Directives”). They also contain the legislative measures necessary for the implementation, in relation to medical devices, of the agreements on mutual recognition between the European Community and Australia, New Zealand, Canada and the United States of America—and of the Association Agreement between the European Communities, and their Member States, and Hungary.",
  "citation": "S.I. 2002/618",
  "type": "uksi",
  "year": "2002",
  "number": "618",
  "version": "current",
  "date": "2002-05-20",
  "revised": true,
  "valid_from": "2026-04-01",
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 4,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "part/I",
      "kind": "part",
      "number": "I",
      "heading": "Introductory Provisions Relating to all Medical Devices",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/1ZA",
      "kind": "regulation",
      "number": "1ZA",
      "heading": "Expiry of certain provisions in these Regulations",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-1ZA",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/1A",
      "kind": "regulation",
      "number": "1A",
      "heading": "Schedules",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-1A",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-2",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/2A",
      "kind": "regulation",
      "number": "2A",
      "heading": "Medical devices which are qualifying Northern Ireland goods",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-2A",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Scope of these Regulations",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-3",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/3ZA",
      "kind": "regulation",
      "number": "3ZA",
      "heading": "Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-3ZA",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/3A",
      "kind": "regulation",
      "number": "3A",
      "heading": "Designated standard",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-3A",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/3B",
      "kind": "regulation",
      "number": "3B",
      "heading": "Confidentiality",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-3B",
      "extent": "E+W+S",
      "status": "repealed",
      "parent": "part/I"
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Transitional provisions",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/4A",
      "kind": "regulation",
      "number": "4A",
      "heading": "Transitional provisions for hip, knee and shoulder replacements",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4A",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/4D",
      "kind": "regulation",
      "number": "4D",
      "heading": "Revocations, transitional and saving provisions in respect of the new national registration requirements",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4D",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/4H",
      "kind": "regulation",
      "number": "4H",
      "heading": "Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4H",
      "extent": "E+W+S",
      "status": "repealed",
      "parent": "part/I"
    },
    {
      "path": "regulation/4I",
      "kind": "regulation",
      "number": "4I",
      "heading": "Revocation of Commission Decision 2010/227",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4I",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/4J",
      "kind": "regulation",
      "number": "4J",
      "heading": "Revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4J",
      "extent": "E+W+S",
      "status": "repealed",
      "parent": "part/I"
    },
    {
      "path": "regulation/4K",
      "kind": "regulation",
      "number": "4K",
      "heading": "Revocation of Regulation (EU) No 722/2012 on 26th May 2025",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4K",
      "extent": "E+W+S",
      "status": "repealed",
      "parent": "part/I"
    },
    {
      "path": "regulation/4L",
      "kind": "regulation",
      "number": "4L",
      "heading": "Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4L",
      "extent": "E+W+S",
      "status": "repealed",
      "parent": "part/I"
    },
    {
      "path": "regulation/4M",
      "kind": "regulation",
      "number": "4M",
      "heading": "Revocation of Regulation (EU) No 2017/2185 and saving provision",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4M",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/4N",
      "kind": "regulation",
      "number": "4N",
      "heading": "The classification criteria in Directives 2003/12 and 2005/50",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4N",
      "extent": "E+W+S",
      "status": "repealed",
      "parent": "part/I"
    },
    {
      "path": "regulation/4O",
      "kind": "regulation",
      "number": "4O",
      "heading": "Revocation of Regulation (EU) 2017/745",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4O",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/4P",
      "kind": "regulation",
      "number": "4P",
      "heading": "Revocation of Regulation (EU) 2017/746",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4P",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/4T",
      "kind": "regulation",
      "number": "4T",
      "heading": "References in other legislation to Directives 90/385, 93/42 and 98/79",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-4T",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "part/II",
      "kind": "part",
      "number": "II",
      "heading": "General Medical Devices",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Interpretation of Part II",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Scope of Part II",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Classification of general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-7",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/7A",
      "kind": "regulation",
      "number": "7A",
      "heading": "Registration of persons placing general medical devices on the market",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-7A",
      "extent": null,
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Essential requirements for general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-8",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "Determining compliance of general medical devices with relevant essential requirements",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-9",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "UK marking of general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-10",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/10A",
      "kind": "regulation",
      "number": "10A",
      "heading": "UK(NI) indication: general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-10A",
      "extent": "N.I.",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "UK marking of general medical devices that come within the scope of this Part and other legislation",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-11",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Exemptions from regulations 8 and 10",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-12",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Procedures for affixing a UK marking to general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-13",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Procedures for systems and procedure packs, and for devices to be sterilised before use",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-14",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Procedures for custom-made general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-15",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Procedures for general medical devices for clinical investigations",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-16",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Manufacturers etc. and conformity assessment procedures for general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-17",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Approved bodies and the conformity assessment procedures for general medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-18",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "Registration of persons placing general medical devices on the market",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/19A",
      "kind": "regulation",
      "number": "19A",
      "heading": "Additional requirements relating to use of animal tissues",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-19A",
      "extent": null,
      "status": "repealed",
      "parent": "part/II"
    },
    {
      "path": "regulation/19B",
      "kind": "regulation",
      "number": "19B",
      "heading": "Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-19B",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "regulation/19C",
      "kind": "regulation",
      "number": "19C",
      "heading": "Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-19C",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/II"
    },
    {
      "path": "part/III",
      "kind": "part",
      "number": "III",
      "heading": "Active Implantable Medical Devices",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Interpretation of Part III",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Scope of Part III",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-21",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/21A",
      "kind": "regulation",
      "number": "21A",
      "heading": "Registration of persons placing active implantable medical devices on the market",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-21A",
      "extent": null,
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/21B",
      "kind": "regulation",
      "number": "21B",
      "heading": "Registration of persons placing active implantable medical devices on the market",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-21B",
      "extent": "N.I.",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/21C",
      "kind": "regulation",
      "number": "21C",
      "heading": "Requirement to appoint a UK responsible person for active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-21C",
      "extent": "N.I.",
      "status": "repealed",
      "parent": "part/III"
    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "number": "22",
      "heading": "Essential requirements for active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-22",
      "extent": null,
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Determining compliance of active implantable medical devices with relevant essential requirements",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-23",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/24",
      "kind": "regulation",
      "number": "24",
      "heading": "UK marking of active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-24",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/24A",
      "kind": "regulation",
      "number": "24A",
      "heading": "UK(NI) indication: active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-24A",
      "extent": "N.I.",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "heading": "UK marking of active implantable medical devices that come within the scope of this Part and other legislation",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-25",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "Exemptions from regulations 22 and 24",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-26",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/27",
      "kind": "regulation",
      "number": "27",
      "heading": "Procedures for affixing a UK marking to active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-27",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Procedures for custom-made active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-28",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/29",
      "kind": "regulation",
      "number": "29",
      "heading": "Procedures for active implantable medical devices for clinical investigations",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-29",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/30",
      "kind": "regulation",
      "number": "30",
      "heading": "Manufacturers etc. and conformity assessment procedures for active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-30",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/30A",
      "kind": "regulation",
      "number": "30A",
      "heading": "Obligations in Part III which are met by complying with obligations in Directive 90/385",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-30A",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "regulation/31",
      "kind": "regulation",
      "number": "31",
      "heading": "Approved bodies and the conformity assessment procedures for active implantable medical devices",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-31",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/III"
    },
    {
      "path": "part/IV",
      "kind": "part",
      "number": "IV",
      "heading": "In Vitro Diagnostic Medical Devices",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/32",
      "kind": "regulation",
      "number": "32",
      "heading": "Interpretation of Part IV",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-32",
      "extent": "E+W+S",
      "status": null,
      "parent": "part/IV"
    },
    {
      "path": "regulation/33",
      "kind": "regulation",
      "number": "33",
      "heading": "Scope of Part IV",
      "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-33",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/IV"
    },
    {
      "path": "regulation/33A",
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