{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-4/paragraph-3",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-4/paragraph-3.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/4/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Undertaking",
  "text": "The manufacturer shall undertake to keep available for the Secretary of State—\n(a) for custom-made devices, documentation in English enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of the Directive to be assessed;\n(b) for devices intended for clinical investigation, that documentation and the following additional documentation in English:—\n(i) a general description of the product,\n(ii) design drawings, particulars of methods of manufacture, in particular as regards sterilisation, and diagrams of parts, sub-assemblies, circuits and similar items,\n(iii) the descriptions and explanations necessary for the understanding of those drawings and diagrams and of the operation of the product,\n(iv) a list of the relevant national Standards applied in full or in part, and a description of the measures taken to comply with the relevant essential requirements where those Standards have not been applied,\n(v) the results of the design calculations, checks and technical tests carried out.",
  "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/4/paragraph/3",
    "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."
}