{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-9",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-9.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/2/paragraph/9",
  "kind": "paragraph",
  "number": "9",
  "heading": "Requirements as to design and construction",
  "text": "The device shall be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in paragraphs 1 to 5 with particular attention being paid to—\n(a) the choice of materials used, particularly as regards toxicity;\n(b) mutual compatibility between the materials used and biological tissues, cells and body fluids (acccount being taken in accordance with regulation 3(2) of the intended use of the device);\n(c) compatibility of the device with any substances which it is intended to administer;\n(d) the quality of the connections, particularly where considerations of safety are involved;\n(e) the reliability of the source of energy;\n(f) if appropriate, the need to make it leakproof;\n(g) proper functioning of the programming and control systems, including software.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/3146/schedule/2/paragraph/9",
    "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."
}