{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-1",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-1.json",
  "legislation": "uksi/1992/3146",
  "legislation_title": "The Active Implantable Medical Devices Regulations 1992",
  "legislation_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992",
  "path": "schedule/2/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "General requirements",
  "text": "(1) The device shall be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down by the manufacturer, its use does not compromise the clinical condition or the safety of the patient.\n(2) The device shall not present any foreseeable risk to the person implanting it or to other persons.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/3146/schedule/2/paragraph/1",
    "retrieved_at": "2026-10-29T14:09:16.889291+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."
}