{
  "url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-43",
  "json_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-43.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/43",
  "kind": "paragraph",
  "number": "43",
  "heading": "Substitution of regulation 6(7)",
  "text": "For regulation 6(7) substitute—\n“(7) In regulation 42 (UK notified bodies and the conformity assessment procedures for in vitro diagnostic devices)—\n(a) in the heading, for “UK notified bodies” substitute “Approved bodies”;\n(b) in paragraph (1)—\n(i) in the opening words, for “A UK notified body” substitute “An approved body”;\n(ii) in sub-paragraph (a) omit “in accordance with Directive 98/79”;\n(iii) in sub-paragraph (b) omit the words from “including in particular” to the end of that sub-paragraph (but not the “and” following it);\n(iv) in sub-paragraph (c) for “his authorised representative” substitute “their UK responsible person”;\n(c) in paragraph (2) for “a UK notified body” substitute “an approved body”;\n(d) in paragraph (3)—\n(i) for “a UK notified body” substitute “an approved body”;\n(ii) for “his authorised representative” in both places it occurs substitute “their UK responsible person”.”.",
  "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/43",
    "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."
}