{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-6/paragraph-4",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-6/paragraph-4.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/4",
  "kind": "paragraph",
  "number": "4",
  "heading": "Approval",
  "text": "(1) Where the type complies with the provisions of the Directive, the notified body shall signify approval by issuing an EC type-examination certificate to the applicant.\n(2) A certificate relating to a type shall contain the name and address of the manufacturer, the conclusions of the evaluation of the type, the conditions under which the certificate is valid and the information necessary for identification of the type.\n(3) The notified body shall attach to the certificate what it considers to be the significant parts of the documentation and shall keep a copy of the certificate and of those parts of the documentation.",
  "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/4",
    "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."
}