{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-8/paragraph-1",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-8/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/8/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": null,
  "text": "(1) The manufacturer shall make an application in writing for evaluation of his quality system to a notified body.\n(2) The application shall be signed by or on behalf of the manufacturer and shall include—\n(a) the information and undertakings which are required by paragraph 2 of Schedule 5 to be included in an application under paragraph 1 of that Schedule, other than the information required by paragraph 2(1)(e) of that Schedule so far as it relates to research and development and design;\n(b) the technical documentation relating to the approved type and a copy of the EC type-examination certificate.",
  "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/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."
}