{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-34",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-34.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/34",
  "kind": "regulation",
  "number": "34",
  "heading": "Essential requirements for in vitro diagnostic medical devices",
  "text": "(1) Subject to regulation 39, 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.\n(2) Subject to regulation 39, 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, unless that device meets those essential requirements set out in Annex I which apply to it.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/34",
    "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."
}