{
  "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024",
  "json_url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024.json",
  "id": "ukdsi/2024/9780348264593",
  "title": "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024",
  "short_title": "Medical Devices (Post-market Surveillance Requirements) 2024",
  "long_title": "These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to insert new post-market surveillance requirements. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972 to implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC.",
  "citation": "Draft 2024, ISBN 9780348264593",
  "type": "ukdsi",
  "year": "2024",
  "number": "9780348264593",
  "version": "current",
  "date": null,
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation, commencement, extent and application",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-1",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Amendments to the Medical Devices Regulations 2002",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-2",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Amendment to regulation 2 (interpretation)",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-3",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "New Part 4A (post-market surveillance requirements)",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-4",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Amendment to Schedule 2A",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-5",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Saving provision",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-6",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "has_text": true,
  "pdfs": [
    {
      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "2024-10-21",
      "size": 101273,
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/pdf/ukdsi_9780348264593_en.pdf",
      "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348264593/pdfs/ukdsi_9780348264593_en.pdf"
    },
    {
      "title": "UK Draft Explanatory Memorandum",
      "main": false,
      "language": null,
      "date": "2024-10-21",
      "size": 72245,
      "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/pdf/ukdsiem_9780348264593_en_001.pdf",
      "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348264593/pdfs/ukdsiem_9780348264593_en_001.pdf"
    }
  ],
  "outstanding_effects": [],
  "made_under": [
    {
      "id": "ukpga/2021/3",
      "title": "Medicines and Medical Devices Act 2021",
      "url": "https://openlegislation.uk/medicines-and-medical-devices-act-2021",
      "provisions": [
        "section/15",
        "section/16",
        "section/17",
        "section/43"
      ]
    }
  ],
  "changes_made_to": 0,
  "changes_made_to_url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348264593",
    "retrieved_at": "2026-10-30T14:40:30.334016+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."
}