{
  "url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/schedule-2",
  "json_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/schedule-2.json",
  "legislation": "uksi/2021/905",
  "legislation_title": "The Medical Devices (Northern Ireland Protocol) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021",
  "path": "schedule/2",
  "kind": "schedule",
  "number": "2",
  "heading": "Fees in connection with the designation of notified bodies",
  "text": "Table 1\nApplication fees\nApplication\nFee\n1. For initial designation submitted under Article 38 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746\n£41,337\n2. For initial designation re-submitted under Article 38 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746 where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application\n£10,335\n3. For reassessment under Article 44(10) of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746\n£41,337\n4. For an extension of the scope of the designation under Article 46(1) of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746 which extends the body’s designation to carry out tasks included in an Annex to Regulation (EU) 2017/745 or Regulation (EU) 2017/746 that was not previously within the body’s designation\n£14,568\n5. For an extension of the scope of the designation under Article 46(1) of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746 which extends the body’s designation to carry out tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required\n£21,105\nTable 2\nFees for assessments and reviews\nActivity\nFee\n1. On-site assessment under Article 39(4) of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746 in connection with an application for initial designation under Article 38 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746, or an application for reassessment under Article 44(10) of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746\n£67,606\n2. On-site audit as part of an annual reassessment under Article 44(4) of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746\n£52,929\n3. Observed audit of notified body personnel under Article 44(5) of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746\n£11,672\n4. On-site assessment of a subsidiary\n£26,408\n5. ‘For-cause’ review under Article 44(7) of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746 to—\n(a) review assessments by the notified body, including clinical evaluation documentation;\n(b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 , or Regulation (EU) 2017/746 or address a particular issue\n(a) £21,535\n(b) £26,408",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(ii)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(b)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iii)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(c)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in Sch. 2 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(2)(a)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iv)(aa)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iv)(bb)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(d)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Words in Sch. 2 Table 1 inserted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(2)(b)"
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(v)"
    },
    {
      "type": "F",
      "label": "F13",
      "text": "Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(e)"
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(aa)"
    },
    {
      "type": "F",
      "label": "F15",
      "text": "Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(bb)"
    },
    {
      "type": "F",
      "label": "F16",
      "text": "Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(cc)"
    },
    {
      "type": "F",
      "label": "F17",
      "text": "Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(a)"
    },
    {
      "type": "F",
      "label": "F18",
      "text": "Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(ii)"
    },
    {
      "type": "F",
      "label": "F19",
      "text": "Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(b)"
    },
    {
      "type": "F",
      "label": "F20",
      "text": "Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iii)"
    },
    {
      "type": "F",
      "label": "F21",
      "text": "Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(c)"
    },
    {
      "type": "F",
      "label": "F22",
      "text": "Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(d)"
    },
    {
      "type": "F",
      "label": "F23",
      "text": "Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iv)(aa)"
    },
    {
      "type": "F",
      "label": "F24",
      "text": "Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iv)(bb)"
    },
    {
      "type": "F",
      "label": "F25",
      "text": "Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(e)(i)"
    },
    {
      "type": "F",
      "label": "F26",
      "text": "Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(e)(ii)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Sch. 2 in force at 27.7.2021, see reg. 1(2)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2021/905/schedule/2",
    "retrieved_at": "2026-10-28T22:10:11.075057+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."
}