{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-8/paragraph-4",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-8/paragraph-4.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/8/paragraph/4",
  "kind": "paragraph",
  "number": "4",
  "heading": null,
  "text": "The manufacturer shall authorise the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:\n(a) the documentation relating to the quality system documentation;\n(b) the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardisations, calibrations, the qualifications of the staff concerned, etc.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/3146/schedule/8/paragraph/4",
    "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."
}