{
  "url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/schedule-1",
  "json_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/schedule-1.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/1",
  "kind": "schedule",
  "number": "1",
  "heading": "Fees for clinical investigations",
  "text": "Table 1\nClinical investigation of a class I device, class IIa device or class IIb device, which is neither an implantable device nor a long-term invasive device\nActivity\nFee\n1. Application submitted under Article 70(1)\n£15,309\n2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)\n£11,701\n3. Notification of a substantial modification under Article 75(1)\n£226\nTable 2\nClinical investigation of a class IIb device, which is either an implantable device or a long-term invasive device, or a class III device\nActivity\nFee\n1. Application submitted under Article 70(1)\n£32,016\n2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)\n£22,678\n3. Notification of a substantial modification under Article 75(1)\n£361",
  "extent": "N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 1 Table 1 heading substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(2)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sum in Sch. 1 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), 21(2)(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sum in Sch. 1 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), 21(2)(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sum in Sch. 1 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), 21(2)(c)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sch. 1 Table 2 heading substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(4)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in Sch. 1 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), 21(3)(a)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Sum in Sch. 1 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), 21(3)(b)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Sum in Sch. 1 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), 21(3)(c)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Sch. 1 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/1",
    "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."
}