{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-40",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-40.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/40",
  "kind": "regulation",
  "number": "40",
  "heading": "Procedures for affixing a UK marking to in vitro diagnostic medical devices",
  "text": "(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a UK marking only if its manufacturer or their UK responsible person—\n(a) fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;\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 which is a device for self-testing but which is not referred to in a list in Annex II may bear a UK marking only if its manufacturer or their UK responsible person—\n(a) fulfils the applicable obligations imposed by—\n(i) Sections 1 to 6 of Annex III,\n(ii) Annex IV, or\n(iii) Annex V and either Annex VI or Annex VII;\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 referred to in List A in Annex II 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 IV, or\n(ii) Annexes V and VII;\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 referred to in List B in Annex II 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 IV,\n(ii) Annexes V and VI, or\n(iii) Annexes V and VII;\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.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 40 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 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/40",
    "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."
}