{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-8",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-8.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/8",
  "kind": "regulation",
  "number": "8",
  "heading": "Essential requirements for general medical devices",
  "text": "(1) Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).\n(2) Subject to regulation 12, no person shall supply a relevant device—\n(a) if that supply is also a placing on the market or putting into service of that device; or\n(b) in circumstances where that device has been placed on the market or put into service,\nunless that device meets those essential requirements set out in Annex I which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).\n(3) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 8(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 8(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 8(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 5"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 8(3) substituted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(5) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "E",
      "label": "E1",
      "text": "This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/8",
    "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."
}