{
  "url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-16",
  "json_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-16.json",
  "legislation": "ukdsi/2020/9780348214956",
  "legislation_title": "The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020",
  "path": "schedule/2/paragraph/16",
  "kind": "paragraph",
  "number": "16",
  "heading": "Substitution of regulation 4(7)",
  "text": "For regulation 4(7) substitute—\n“(7) In regulation 12 (exemptions from regulations 8 and 10)—\n(a) in paragraph (1) omit “Directive 93/42 or”;\n(b) in paragraph (3)(a) for “CE marking” substitute “UK marking”;\n(c) in paragraph (5) for “CE marking” substitute “UK marking”;\n(d) after paragraph (5) insert—\n“(6) Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a UK marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market.\n(7) In paragraph (6), the Secretary of State, in determining whether another standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.”.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/16",
    "retrieved_at": "2026-10-30T14:48:13.546182+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."
}