{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-18",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-18.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/18",
  "kind": "paragraph",
  "number": "18",
  "heading": null,
  "text": "In Annex VII—\n(a) in the title and in Section 1, omit “EC”;\n(b) in Section 1—\n(i) for “authorised representative” substitute “UK responsible person”;\n(ii) for “this Directive” substitute “the Regulations”;\n(c) in Section 2 for—\n(i) “his authorised representative” substitute “the manufacturer’s UK responsible person”;\n(ii) “national authorities” substitute “Secretary of State”;\n(d) in Section 3—\n(i) in the opening paragraph for “the Directive” substitute “the Regulations”;\n(ii) in the fourth indent—\n(aa) for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;\n(bb) for “of the Directive” substitute “in Annex I”;\n(e) omit Section 4;\n(f) in Section 5, for “the intervention by the notified body” substitute “the intervention by the approved body”;\n(g) in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”.",
  "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. 18(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(10) (with reg. 6)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/18",
    "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."
}