{
  "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2008/regulation-12",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2008/regulation-12.json",
  "legislation": "uksi/2008/2936",
  "legislation_title": "The Medical Devices (Amendment) Regulations 2008",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2008",
  "path": "regulation/12",
  "kind": "regulation",
  "number": "12",
  "heading": "Amendment of regulation 21 of the principal Regulations",
  "text": "In regulation 21 of the principal Regulations (scope of Part III)—\n(a) the existing paragraph shall be numbered (1); and\n(b) after paragraph 1 add—\n“(2) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.\n(3) Where an active implantable medical device is intended to administer a medicinal product, that device shall be governed by Directive 90/385 without prejudice to the provisions of Directive 2001/83/EC.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2008/2936/regulation/12",
    "retrieved_at": "2026-10-29T03:22:08.877648+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."
}