{
  "url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-3",
  "json_url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-3.json",
  "legislation": "ukdsi/2021/9780348224795",
  "legislation_title": "The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Amendment of the Medical Devices Regulations 2002",
  "text": "In regulation 2 after the definition of “clinical data”, insert—\n““coronavirus test device” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 2 has been amended on a number of occasions, most recently by S.I. 2020/1478. The definition of “clinical data” was inserted by S.I. 2008/2936."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224795/regulation/3",
    "retrieved_at": "2026-10-30T14:46:56.445827+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."
}