{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-17",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-17.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/17",
  "kind": "paragraph",
  "number": "17",
  "heading": null,
  "text": "In Annex VI—\n(a) omit “EC” each time it occurs including in the title;\n(b) for “the notified body” each time it occurs substitute “the approved body”;\n(c) for “this Directive” each time it occurs substitute “the Regulations”;\n(d) in Section 2—\n(i) for “CE marking in accordance with Article 17” substitute “UK marking”;\n(ii) for “CE marking must” substitute “UK marking must”;\n(e) in Section 3.1–\n(i) for “a notified body” substitute “an approved body”;\n(ii) for “other notified body” substitute “other approved body”;\n(iii) omit the eighth indent;\n(f) in Section 3.3, for the first sentence 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.”;\n(g) in Section 3.4, for the second paragraph substitute—\n“The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.”;\n(ga) in Section 4.4 for “Article 5” substitute “regulation 3A of the Regulations”;\n(h) in Section 5.1—\n(i) for “authorised representative” substitute “UK responsible person”;\n(ii) for “national authorities” substitute “Secretary of State”;\n(i) in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;\n(j) in Section 6.3, for “competent authority” substitute “Secretary of State”.\n(k) in Section 6.4 for “notified body” substitute “approved body”.",
  "extent": "E+W+S",
  "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. 17(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(9) (with reg. 6)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sch. 2A para. 17(ga) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(h)(ii)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sch. 2A para. 17(k) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(h)(iii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/17",
    "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."
}