{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-27",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-27.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "schedule/2A/paragraph/27",
  "kind": "paragraph",
  "number": "27",
  "heading": null,
  "text": "In Annex IV—\n(a) in the title, omit “EC”;\n(b) for each reference to “this Directive” and “the Directive” substitute “the Regulations”;\n(c) in Section 2, for “CE marking” substitute “UK marking”;\n(d) in Section 3.1—\n(i) for “of his quality system with a notified body” substitute “of its quality system with an approved body”;\n(ii) in the third indent for “notified body” substitute “approved body”;\n(iii) omit the final indent;\n(e) in Section 3.3 for the first paragraph substitute—\n“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to the requirements.”;\n(f) in Section 3.4, in both paragraphs, for “notified body” substitute “approved body”;\n(g) in Section 4.1 for “notified body” substitute “approved body”;\n(h) in Section 4.3—\n(i) for “notified body” both times those words occur substitute “approved body”;\n(ii) for “an EC” substitute “a”;\n(i) in Section 4.4—\n(i) for “notified body” both times those words occur substitute “approved body”;\n(ii) omit each reference to “EC”;\n(j) in Section 4.5, for “notified body” both times those words occur substitute “approved body”;\n(k) in Sections 5 and 6 for “notified body” each time those words occur substitute “approved body”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 12 (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 56, 57); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 2A para. 27(d)(iii) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(13) (with reg. 6)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/27",
    "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."
}