{
  "url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-11",
  "json_url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-11.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/11",
  "kind": "regulation",
  "number": "11",
  "heading": "Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)",
  "text": "In regulation 2A—\n(a) in paragraph (1)—\n(i) before “Notwithstanding” insert “Subject to paragraph (1A),”;\n(ii) for sub-paragraph (a) substitute—\n“(a) which meets the requirements of—\n(i) these Regulations as they apply in Northern Ireland;\n(ii) Regulation (EU) 2017/745; or\n(iii) Regulation (EU) 2017/746; and”;\n(b) after paragraph (1) insert—\n“(1A) Before 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of—\n(a) regulation 34A (approval requirement for coronavirus test devices); or\n(b) the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 2A was inserted by S.I. 2019/791 and amended by S.I. 2021/905."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2023/9780348253696/regulation/11",
    "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."
}