{
  "url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-3",
  "json_url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024/regulation-3.json",
  "legislation": "ukdsi/2024/9780348264593",
  "legislation_title": "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Amendment to regulation 2 (interpretation)",
  "text": "In regulation 2(1)—\n(a) for the definition of “relevant essential requirements” substitute—\n““relevant essential requirements”—\n(a) in Part 4A, has the meaning given in regulation 44ZC;\n(b) in all other Parts, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;”;\n(b) for the definition of “Regulation (EU) No 722/2012” substitute—\n““Regulation (EU) No 722/2012”—\n(a) in Part 4A, has the meaning given in regulation 44ZC;\n(b) in all other Parts means 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 (as retained under section 3 of the European Union (Withdrawal) Act 2018 and modified under section 8 of that Act);”;\n(c) after the definition of “UK responsible person” insert—\n““working day” means any day which is not Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday in any part of Great Britain under the Banking and Financial Dealings Act 1971.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Relevant amending instruments are S.I. 2003/1697, 2013/2327, 2021/873."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348264593/regulation/3",
    "retrieved_at": "2026-10-30T14:40:30.334016+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."
}