{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-3/paragraph-1",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-3/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/3/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "Basis of clinical data",
  "text": "(1) Adequacy of the clinical data presented as part of the particulars referred to in paragraph 6(2) of Schedule 5 or included in the documentation mentioned in paragraphs 1(c) and 2 of Schedule 6 shall be based, account being taken as appropriate of relevant harmonised Standards, on either:\n(a) a collation of currently available, relevant scientific literature covering the intended use of the device and the techniques for it as well as, if appropriate, a written report making a critical assessment of that collation; or\n(b) the results of all clinical investigations made, and, in particular, the results of those carried out in accordance with paragraphs 2, 3 and 4.\n(2) All the data presented must remain confidential unless it is essential that they be divulged.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "amended",
      "affecting": "uksi/1995/1671",
      "affecting_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/3146/schedule/3/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."
}