{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-39A",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-39A.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/39A",
  "kind": "regulation",
  "number": "39A",
  "heading": "Exemptions for coronavirus test devices",
  "text": "(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test devices of a particular class or description that has not been approved under regulation 38A(5); and\n(b) has not withdrawn that permission.\n(2) The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the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": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 39A inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 8"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/39A",
    "retrieved_at": "2026-10-29T07:11:50.089580+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."
}