{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995/regulation-12",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995/regulation-12.json",
  "legislation": "uksi/1995/1671",
  "legislation_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995",
  "legislation_url": "https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995",
  "path": "regulation/12",
  "kind": "regulation",
  "number": "12",
  "heading": "Amendment of regulation 12 of the principal Regulations",
  "text": "(1) Regulation 12 of the principal Regulations (notification of decisions etc.) shall be amended in accordance with the following provisions of this regulation.\n(2) After paragraph (1) there shall be inserted the following paragraph—\n“(1A) Except in cases of emergency, before the Secretary of State or a notified body makes a decision referred to in paragraph (1), the manufacturer or his authorised representative shall have an opportunity to submit his comments to the Secretary of State who, or the notified body which, is considering making such decision.”.\n(3) In paragraph (2) for “paragraph (1)” there shall be substituted the words “paragraphs (1) and (1A)”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1671/regulation/12",
    "retrieved_at": "2026-10-29T13:06:42.505465+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."
}