{
  "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003.json",
  "id": "uksi/2003/1697",
  "title": "The Medical Devices (Amendment) Regulations 2003",
  "short_title": "Medical Devices 2003",
  "long_title": "These Regulations amend the Medical Devices Regulations 2002 (“the principal Regulations”), which contain the legislative measures necessary for the implementation of the European Community scheme for regulating the placing on the market and putting into service of medical devices. The amendments include amendments that are necessary for the implementation of Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants within the framework of Directive 93/42/EEC on medical devices (“Directive 2003/12”) and Commission Directive 2003/32 of 23rd April 2003 on medical devices utilising tissues of animal origin (“Directive 2003/32”).",
  "citation": "S.I. 2003/1697",
  "type": "uksi",
  "year": "2003",
  "number": "1697",
  "version": "current",
  "date": "2003-07-04",
  "revised": true,
  "valid_from": "2013-10-21",
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation, commencement and interpretation",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-1",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Amendment of regulation 2 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Amendment of regulation 4 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-3",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Amendment of regulation 5 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-4",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Amendment of regulation 7 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-5",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Amendment of regulation 13 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-6",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Amendment of regulation 17 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-7",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Amendment of regulation 18 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-8",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "New regulation 19A of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-9",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "Amendment of regulation 20 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-10",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "Amendment of regulation 32 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-11",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "New regulation 44A of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-12",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Amendment of regulation 45 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-13",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Amendment of regulation 47 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-14",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Amendment of regulation 52 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-15",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Amendment of regulation 54 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-16",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Amendment of regulation 59 of the principal Regulations",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-17",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "outstanding_effects": [],
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  "changes_made_to_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/changes.json",
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2003/1697",
    "retrieved_at": "2026-10-29T06:16:48.278874+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."
}