{
  "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2013/note",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2013/note.json",
  "legislation": "uksi/2013/2327",
  "legislation_title": "The Medical Devices (Amendment) Regulations 2013",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2013",
  "path": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations amend the Medical Devices Regulation 2002 (the 2002 Regulations) in order to implement Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices and Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin.\nRegulation 2(4) to (6) ensures that the requirements directly imposed under Commission Regulation (EU) No 207/2012 on manufacturers who adopt electronic labelling of medical devices are enforceable in the UK.\nRegulations 2(2), (4) and (5), 3 to 7, 9 to 17 and 21 ensure that the requirements directly imposed under Commission Regulation (EU) No 722/2012 on manufacturer of medical devices that utilise tissue of animal origin are enforceable in the UK; and remove national requirements which duplicate requirements directly applicable under the Commission Regulation.\nRegulations 2(2) and (3), 8, 19 and 20 update the 2002 Regulations to take account of changes in the membership of the European Union.\nRegulation 18 requires the Secretary of State to review the 2002 Regulations and publish a report by 31st December 2019.\nA full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public or voluntary sectors is foreseen.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/2327/note",
    "retrieved_at": "2026-10-29T00:41:18.815669+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."
}