{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995/regulation-4",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995/regulation-4.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/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Amendment of regulation 3(4) of the principal Regulations",
  "text": "For paragraph (4) of regulation 3 of the principal Regulations (essential requirements for devices) there shall be substituted the following paragraphs—\n“(4) In the case of a device which has been put into service—\n(a) the essential requirements specified in paragraph 14 of Schedule 2 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and\n(b) the essential requirements specified in paragraph 13, so far as they relate to instructions required for the operation of a device and in paragraph 15 of Schedule 2, are complied with only if the instructions are in English or another Community language.\n(4A) Where the instructions for use referred to in paragraph (4)(b) are not in English, any packaging, label or promotional literature must carry a clear statement in English stating the language in which the instructions are given.”.",
  "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/4",
    "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."
}