{
  "url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-22",
  "json_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-22.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/22",
  "kind": "paragraph",
  "number": "22",
  "heading": "Substitution of regulation 4(9)",
  "text": "For regulation 4(9) substitute—\n“(9) In regulation 18 (UK notified bodies and the conformity assessment procedures for general medical 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 93/42”;\n(iii) in sub-paragraph (b) omit the words from “including in particular” to “EEA State”;\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, substitute “the manufacturer’s UK responsible person”;\n(e) omit paragraph (4).”.",
  "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/22",
    "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."
}