{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-13",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-13.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/13",
  "kind": "regulation",
  "number": "13",
  "heading": "Procedures for affixing a UK marking to general medical devices",
  "text": "(1) A relevant device falling within Class I may bear a UK marking only if its manufacturer or their UK responsible person—\n(a) fulfils the applicable obligations imposed by Annex VII;\n(b) declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of this Part which apply to it; and\n(c) ensures that the device meets the provisions of this Part which apply to it.\n(2) A relevant device falling within Class IIa may bear a UK marking only if its manufacturer or their UK responsible person—\n(a) fulfils the applicable obligations imposed by—\n(i) Annex II, excluding Section 4 of that Annex, or\n(ii) Annex VII, together with Annex IV, V or VI;\n(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and\n(c) ensures that the device meets the provisions of this Part which apply to it.\n(3) A relevant device falling within Class IIb may bear a UK marking only if its manufacturer or their UK responsible person—\n(a) fulfils the applicable obligations imposed by—\n(i) Annex II, excluding Section 4 of that Annex, or\n(ii) Annex III, together with Annex IV, V or VI;\n(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and\n(c) ensures that the device meets the provisions of this Part which apply to it.\n(4) A relevant device falling within Class III may bear a UK marking only if its manufacturer or their UK responsible person—\n(a) fulfils the applicable obligations imposed by—\n(i) Annex II, or\n(ii) Annex III, together with Annex IV or V;\n(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; ...\n(c) ensures that the device meets the provisions of this Part which apply to it; and\n(d) fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).\n(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Word in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Word in reg. 13(4)(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(b)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Reg. 13(5)(6) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(3)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in reg. 13 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "E",
      "label": "E1",
      "text": "This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/13",
    "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."
}