{
  "url": "https://openlegislation.uk/health-protection-coronavirus-testing-requirements-and-standards-england-regulations-2020/regulation-4",
  "json_url": "https://openlegislation.uk/health-protection-coronavirus-testing-requirements-and-standards-england-regulations-2020/regulation-4.json",
  "legislation": "uksi/2020/1549",
  "legislation_title": "The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/health-protection-coronavirus-testing-requirements-and-standards-england-regulations-2020",
  "path": "regulation/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Test requirements",
  "text": "(1) Any device used for the purposes of an applicable test must meet the following requirements—\n(a) it can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002 , other than solely by virtue of regulation 39(2) of those Regulations;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(3) In this regulation—\n(a) “device” means an in vitro diagnostic medical device within the meaning given in regulation 2(1) of the Medical Devices Regulations 2002;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 4(1)(b) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(2) (with reg. 9)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 4(2) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(3) (with reg. 9)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 4(3)(b) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(4) (with reg. 9)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 4(3)(c) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(4) (with reg. 9)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 2002/618, as amended by S.I. 2003/1697. Further amendments are prospectively made by S.I. 2019/791 with effect from 1st January 2021. There are other amending instruments not relevant to these Regulations."
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 4 in force at 17.12.2020, see reg. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2020/1549/regulation/4",
    "retrieved_at": "2026-10-28T22:20:08.085387+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."
}