{
  "url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-16",
  "json_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-16.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": "regulation/16",
  "kind": "regulation",
  "number": "16",
  "heading": "Clinical investigation fees",
  "text": "(1) The sponsor of a clinical investigation must pay the relevant fee for—\n(a) an application submitted to the Secretary of State under Article 70(1);\n(b) a notification to the Secretary of State of a substantial modification under Article 75(1).\n(2) The relevant fee is payable when the application or notification to which it relates is made to the Secretary of State.\n(3) If a sponsor fails to pay the relevant fee, the Secretary of State may reject the application, reject the notification or suspend the clinical investigation until the fee is paid.\n(4) Fees for clinical investigations are set out in Schedule 1.\n(4A) Where the relevant fee is payable pursuant to paragraph (1)(a) by a small company, if the small company so requests to the Secretary of State in writing, 50% of that fee shall be payable when the application to which it relates is submitted to the Secretary of State and 50% of that fee shall be payable within six months of the date on which the application was submitted.\n(4B) For the purpose of this regulation, a company is a small company if, for the financial year before that in which the application or notification is submitted or given, the total value of products it has sold or supplied for the financial year is not more than the amount specified in item 1 in section 382(3) (qualification of company as small) of the Companies Act 2006 and either—\n(a) the company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount specified in item 2 in section 382(3) of that Act; or\n(b) the average number of persons employed by the company in the financial year before that in which the application or notice is submitted or given (determined on a weekly basis) does not exceed the number specified in item 3 in section 382(3) of that Act.\n(4C) In this regulation, a reference to section 382 of the Companies Act 2006 is a reference to that section as amended by the Companies (Accounts and Reports) (Amendment and Transitional Provision) Regulations 2024.\n(5) In this regulation, “the relevant fee” means—\n(a) for a clinical 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, the fee in table 1 in Schedule 1, and\n(b) for a clinical investigation of a class IIb device, which is either an implantable device or a long-term invasive device or a class III device, the fee in table 2 in Schedule 1.",
  "extent": "N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 16(4A)-(4C) inserted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 16"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 16(5)(a) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 20(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 16(5)(b) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 20(b)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 16 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/regulation/16",
    "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."
}