{
  "url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-8",
  "json_url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-8.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/8",
  "kind": "regulation",
  "number": "8",
  "heading": "Amendment of the Medical Devices Regulations 2002",
  "text": "After regulation 39, insert—\n“Exemptions for coronavirus test devices\n39A. (1) Regulation 34A does not apply where, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, the Secretary of State—\n(a) has decided to permit, where appropriate for a specified period, the placing on the market or putting into service of a particular coronavirus test device or coronavirus test devices of a particular class or description that has not been approved under regulation 38A(5); and\n(b) has not withdrawn that permission.\n(2) The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the Secretary of State.\n(3) If the Secretary of State publishes a protocol for the purpose of paragraph (2), the protocol must specify the period of time for which it has effect.\n(4) The Secretary of State may withdraw or amend a protocol published under paragraph (2).”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224795/regulation/8",
    "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."
}