{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-7/paragraph-2",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-7/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/7/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": null,
  "text": "(1) The manufacturer shall undertake to the notified body to institute and keep up-dated a system of post-marketing surveillance.\n(2) The undertaking shall include an obligation for the manufacturer to notify the Secretary of State of the following events immediately on learning of them:\n(a) any deterioration in the characteristics or performances of and any inaccuracies in the instruction leaflet for, a device which might lead to or have led to the death of a patient or a deterioration in his state of health;\n(b) any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.",
  "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": "added",
      "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": "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": "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"
    },
    {
      "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/7/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."
}