{
  "url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-19",
  "json_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-19.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/19",
  "kind": "regulation",
  "number": "19",
  "heading": "Fees payable in connection with the designation of notified bodies",
  "text": "(1) Fees in connection with the designation of notified bodies are set out in Schedule 2.\n(2) The applicant must pay the Secretary of State the fee specified in table 1 in Schedule 2 for an application—\n(a) for initial designation as a notified body under Article 38 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746;\n(b) for reassessment under Article 44(10) of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746;\n(c) to extend the scope of a designation under Article 46(1) of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746.\n(3) A notified body designated by the Secretary of State under Article 42 of Regulation (EU) 2017/745 that submits a summary evaluation report to the Secretary of State in accordance with Article 5(4) of Regulation (EU) 722/2012, must pay to the Secretary of State a fee of £1,503.\n(4) A fee specified in table 1 in Schedule 2 or paragraph (3) is payable when the application or submission to which it relates is made to the Secretary of State.\n(5) If an applicant fails to pay a fee specified in table 1 in Schedule 2 or paragraph (3), the Secretary of State may reject the application or submission to which it relates.\n(6) If the Secretary of State conducts an assessment or review listed in table 2 in Schedule 2, the fee payable by the conformity assessment body is—\n(a) the fee specified for that assessment or review in table 2 in Schedule 2,\n(b) an amount for time spent by each member of staff to undertake the assessment or review at a rate—\n(i) for the time spent on site, of £732 per half day (period of less than a half day counting as a half day) up to a maximum of 2 half days on any one date, and\n(ii) for the time spent travelling to and from the site, of £198 per hour,\n(c) the actual costs of travel, accommodation and subsistence, and\n(d) out of pocket expenses.\n(7) A fee under paragraph (6) is payable within one month of receipt by the conformity assessment body of a written notice from the Secretary of State requiring payment of the fee.\n(8) If a conformity assessment body fails to pay a fee under paragraph (6), the Secretary of State may—\n(a) refuse to designate the body under Article 42 of Regulation (EU) 2017/745 or Article 38 of Regulation (EU) 2017/746;\n(b) if the body has already been designated, suspend, restrict, or fully or partially withdraw, the designation.\n(9) In this regulation, “Regulation (EU) 722/2012” means Commission Regulation (EU) No 722/2012 of 8th August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 19(2)(a) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(a)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 19(2)(b) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(a)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 19(2)(c) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(a)(iii)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 19(3) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(b)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sum in reg. 19(3) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 18(a)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in reg. 19(6)(b)(i) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 18(b)(i)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Sum in reg. 19(6)(b)(ii) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 18(b)(ii)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in reg. 19(8)(a) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(c)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 19 in force at 27.7.2021, see reg. 1(2)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L 212, 09.08.2012, p. 3."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2021/905/regulation/19",
    "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."
}