{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-5/paragraph-5",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-5/paragraph-5.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/5/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": "Approval and evaluation of quality system",
  "text": "(1) The manufacturer shall inform the relevant notified body of any plan to modify his approved quality system.\n(2) The relevant notified body shall evaluate the proposed modifications and shall determine whether the quality system as proposed to be modified would fulfil the conditions specified in paragraph 3(2) to (4).\n(3) A decision as to whether or not to approve the system as modified shall be notified to the manufacturer and shall contain a reasoned evaluation and the conclusions of the relevant notified body.\n(4) In this paragraph “relevant notified body” in relation to a quality system means the notified body which approved it, except that where that body is no longer a notified body as respects tasks under this paragraph, it means such other notified body as the Secretary of State shall have designated as the notified body in relation to those tasks and that system.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "amended",
      "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": "substituted",
      "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/5/paragraph/5",
    "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."
}