{
  "url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-29",
  "json_url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-29.json",
  "legislation": "ukdsi/2023/9780348253696",
  "legislation_title": "The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023",
  "path": "regulation/29",
  "kind": "regulation",
  "number": "29",
  "heading": "Amendment to regulation 3 (interpretation)",
  "text": "In regulation 3—\n(a) in paragraph (1)—\n(i) after the definition of “Regulation (EU) 2017/745” insert—\n““Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;”\n(ii) after the definition of “ethics committee” insert—\n““Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators;\n“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.”;\n(b) for paragraph (2) substitute—\n“(2) Unless otherwise defined in these Regulations—\n(a) terms used in Parts 2 and 3 have the same meaning as in Regulation (EU) 2017/745;\n(b) terms used in Parts 2A and 3A have the same meaning as in Regulation (EU) 2017/746.”;\n(c) for paragraph (3) substitute—\n“(3) In these Regulations, a reference to an Article or an Annex is—\n(a) in Parts 2 and 3, a reference to an Article or an Annex of Regulation (EU) 2017/745;\n(b) in Parts 2A and 3A, a reference to an Article or an Annex of Regulation (EU) 2017/746.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 2020/1460."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2023/9780348253696/regulation/29",
    "retrieved_at": "2026-10-30T14:42:17.468953+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."
}