{
  "url": "https://openlegislation.uk/medical-devices-amendment-etc-eu-exit-regulations-2019/regulation-9",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-etc-eu-exit-regulations-2019/regulation-9.json",
  "legislation": "uksi/2019/791",
  "legislation_title": "The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/9",
  "kind": "regulation",
  "number": "9",
  "heading": "Amendment of Part VII of the 2002 Regulations",
  "text": "(1) Part VII of the 2002 Regulations is amended as follows.\n(2) In regulation 59 (interpretation of Part VII)—\n(a) omit the definition of “registrable device”;\n(b) in the definition of “relevant device” after “IV” insert “ or a device for the purposes of Part VIII or IX. ”.\n(3) In regulation 60 (designation etc. of authorised representatives)—\n(a) for the heading substitute “ Status of UK responsible person ”;\n(b) omit paragraphs (1) and (2);\n(c) for paragraph (3), substitute—\n“(3) A UK responsible person—\n(a) may be proceeded against as a person placing the device on the market for the purposes of these regulations;\n(b) in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.”.\n(d) in paragraph (4)—\n(i) for “an authorised representative of a manufacturer of a device” substitute “ a UK responsible person ”;\n(ii) for “the single authorised representative of the manufacturer” substitute “ a UK responsible person ”.\n(4) In regulation 61 (enforcement etc.)—\n(a) for “CE marking” in both places substitute “UK marking”;\n(b) in paragraph (8)(a)(i), after “essential requirement” insert “, a general safety and performance requirement”;\n(c) in paragraph (8)(a)(ii), omit “set out in the Medical Devices Directives”;\n(d) in paragraph (8)(a)(ii)(aa), for “his authorised representative” substitute “their UK responsible person”.\n(5) In regulation 62 (compliance notices) in paragraph (1)—\n(i) after “performance evaluation” insert “ or study ”;\n(ii) for “the manufacturer or his authorised representative” substitute “ any person ”;\n(iii) in sub-paragraph (c) omit “and, where applicable any relevant provision of the Medical Devices Directives”.\n(6) In regulation 63 (restriction notices) in paragraph (1)—\n(i) in sub-paragraph (a), after “performance evaluation” insert “ or study ”;\n(ii) in sub-paragraph (b), after “performance evaluation” insert “ or study ”.\n(6A) In regulation 64 (notification of decisions etc)—\n(a) in paragraph (1)(c), for “him or his authorised representative” substitute “the applicant or the applicant’s UK responsible person”;\n(b) in paragraph (2)—\n(i) for “a UK notified body” substitute “an approved body”;\n(ii) for “his authorised representative” substitute “their UK responsible person”.\n(7) Omit regulation 65(centralised system of records etc.).\n(8) In regulation 67 (review), for “2019” substitute “ 2025 ”.\n(9) Omit Schedule 1 (association agreements).\n(10) For Schedule 2 (mutual recognition agreements) substitute—\n“SCHEDULE 2\nMutual Recognition Agreement countries\nRegulation 1A\n— Australia\n— New Zealand\n— Canada\n— The United States of America\n— The Swiss Confederation”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 9(3)(d) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 2 para. 8; 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 9(4) substituted (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 2 para. 51"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 9(5)(iii) inserted (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 2 para. 52"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 9(6A) inserted (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 2 para. 53"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "Regulation 59 was amended by S.I. 2003/1697."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "Regulation 60 was amended by S.I. 2008/2936."
    },
    {
      "type": "M",
      "label": "M3",
      "text": "Regulation 63 was amended by S.I. 2008/2936."
    },
    {
      "type": "M",
      "label": "M4",
      "text": "Regulation 67 was inserted by S.I. 2013/2327."
    },
    {
      "type": "M",
      "label": "M5",
      "text": "Schedule 1 was amended by 2013/2327."
    },
    {
      "type": "M",
      "label": "M6",
      "text": "Schedule 2 was amended by S.I. 2013/2327."
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 9(1)(3)-(10) in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)"
    },
    {
      "type": "I",
      "label": "I2",
      "text": "Reg. 9(2) in force at 1.5.2021, see reg. 1(2)(e) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2(c))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/791/regulation/9",
    "retrieved_at": "2026-10-28T22:42:01.324222+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."
}