{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-6/paragraph-2",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-6/paragraph-2.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/6/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Making and consideration of application",
  "text": "The documentation referred to in paragraph 1(2)(c) is that which makes it possible to understand the design, the manufacture and the performances of the device, containing in particular the following items:\n(a) a general description of the device;\n(b) design drawings, a description of the methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of parts, sub-assemblies, circuits and other compo nents and accessories;\n(c) the descriptions and explanations necessary for the understanding of those drawings and diagrams and of the operation of the device;\n(d) a list of the relevant national Standards applied in full or in part, and a description of the solutions adopted to satisfy the relevant essential requirements where the relevant national Standards have not been applied;\n(e) the results of design calculations, investigations and technical tests carried out and other design verification data;\n(f) a statement as to whether or not the device incorporates, as an integral part, a substance described in paragraph 10 of Schedule 2 whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted;\n(g) clinical data in accordance with paragraph 1 of Schedule 3;\n(h) the draft instruction leaflet.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "substituted",
      "affecting": "uksi/1995/1671",
      "affecting_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995"
    },
    {
      "type": "amended",
      "affecting": "uksi/1995/1671",
      "affecting_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995"
    },
    {
      "type": "added",
      "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/6/paragraph/2",
    "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."
}