{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-34B",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-34B.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/34B",
  "kind": "regulation",
  "number": "34B",
  "heading": "Public sector use of coronavirus test devices",
  "text": "(1) Regulation 34A(1) does not apply in relation to a coronavirus test device that is placed on the market or put into service only for use by—\n(a) the Secretary of State;\n(b) a devolved public health body; or\n(c) a health service body supplied pursuant to an existing contract.\n(2) Regulation 34A(2) does not apply in relation to a coronavirus test device that is supplied to—\n(a) the Secretary of State;\n(b) a devolved public health body; or\n(c) a health service body pursuant to an existing contract.\n(3) In this regulation—\n“a devolved public health body” is—\n(a)in Wales, Welsh Ministers or Public Health Wales National Health Service Trust;\n(b)in Scotland, Scottish Ministers;\n(c)in Northern Ireland, the Department of Health in Northern Ireland;\n“an existing contract” is a contract entered into before the coming into force of regulation 34A;\n“a health service body” is—\n(a)an NHS body as defined in section 275 of the National Health Service Act 2006 or in section 206 of the National Health Service (Wales) Act 2006;\n(b)a body listed in section 17A(2)(a) to (c) or (e) of the National Health Service (Scotland) Act 1978; or\n(c)a health and social care body as defined in section 1(5)(a) to (e) of the Health and Social Care (Reform) Act (Northern Ireland) 2009.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 34A-34C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 5"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/34B",
    "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."
}