{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-6/paragraph-3",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-6/paragraph-3.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/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Making and consideration of application",
  "text": "The notified body shall—\n(a) examine and evaluate the documentation;\n(b) verify that the type has been manufactured in accordance with that documentation;\n(c) record the items which have been designed in accordance with the applicable provisions of the relevant national Standards, and the items which have not been so designed;\n(d) where the relevant national Standards have not been applied, carry out or have carried out the inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the relevant essential requirements;\n(e) where the manufacturer has chosen to apply the relevant national Standards, carry out or have carried out the inspections and the tests necessary to verify whether they have actually been applied;\n(f) seek agreement with the applicant on the place where the necessary inspections and tests will be carried out.",
  "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/3",
    "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."
}