{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-19",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-19.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/19",
  "kind": "paragraph",
  "number": "19",
  "heading": null,
  "text": "In Annex VIII—\n(a) in Section 1, for “authorized representative” substitute “UK responsible person”;\n(b) in Section 2.2 in the seventh indent for “Directive 2003/32/EC” substitute “Regulation 722/2012”;\n(c) in Section 3, for “competent national authorities” substitute “Secretary of State”;\n(d) in Sections 3.1 and 3.2, for “this Directive” each time it occurs substitute “the Regulations”;\n(e) in Section 3.2—\n(i) in the fourth indent, for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;\n(ii) in the sixth indent, for “Directive 2003/32/EC” substitute “Regulation 722/2012”;\n(f) omit Section 5.",
  "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. 19(f) 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(11) (with reg. 6)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/19",
    "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."
}