{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995/regulation-8",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995/regulation-8.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/8",
  "kind": "regulation",
  "number": "8",
  "heading": "Insertion of regulation 7A into the principal Regulations",
  "text": "After regulation 7 of the principal Regulations (clinical investigations) there shall be inserted the following regulation—\n“Obligations of persons other than manufacturers\n7A (1) Subject to paragraph (2), any obligation of a manufacturer under these Regulations shall extend to a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.\n(2) Paragraph (1) shall not apply to a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.”.",
  "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/8",
    "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."
}