{
  "url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-1/paragraph-17",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-1/paragraph-17.json",
  "legislation": "uksi/2021/873",
  "legislation_title": "The Medical Devices (Amendment) (EU Exit) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021",
  "path": "schedule/1/paragraph/17",
  "kind": "paragraph",
  "number": "17",
  "heading": null,
  "text": "In regulation 36 (UK marking of in vitro diagnostic medical devices), after paragraph (5), insert—\n“(6) In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—\n(a) as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and\n(b) as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Amended by S.I. 2019/791 (as amended by S.I. 2020/1478)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2021/873/schedule/1/paragraph/17",
    "retrieved_at": "2026-10-28T22:10:33.646062+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."
}