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The Medical Devices (Northern Ireland Protocol) Regulations 2021
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- UK Statutory Instruments
- 2021 No. 905
- SCHEDULE 2
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Regulation 19
SCHEDULE 2U.K.Fees in connection with the designation of notified bodies
This schedule has no associated Explanatory Memorandum
Commencement Information
I1Sch. 2 in force at 27.7.2021, see reg. 1(2)
Table 1
Application fees
| Application | Fee |
|---|---|
| 1. For initial designation submitted under Article 38 [F1of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746] | [F2£41,337] |
| 2. For initial designation re-submitted under Article 38 [F3of 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 | [F4£10,335] |
| 3. For reassessment under Article 44(10) [F5of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746] | [F6£41,337] |
| [F74. For an extension of the scope of the designation under Article 46(1) [F8of 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 [F9to Regulation (EU) 2017/745 or Regulation (EU) 2017/746] that was not previously within the body’s designation] | [F10£14,568] |
| [F115. For an extension of the scope of the designation under Article 46(1) [F12of 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] | [F13£21,105] |
Textual Amendments
F1Words 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)
F2Sum 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)
F3Words 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)
F4Sum 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)
F5Words 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)
F6Sum 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)
F7Words 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)
F8Words 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)
F9Words 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)
F10Sum 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)
F11Words 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)
F12Words 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)
F13Sum 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)
Table 2
Fees for assessments and reviews
| Activity | Fee |
|---|---|
| 1. On-site assessment under Article 39(4) [F14of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746] in connection with an application for initial designation under Article 38 [F15of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746], or an application for reassessment under Article 44(10) [F16of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746] | [F17£67,606] |
| 2. On-site audit as part of an annual reassessment under Article 44(4) [F18of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746] | [F19£52,929] |
| 3. Observed audit of notified body personnel under Article 44(5) [F20of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746] | [F21£11,672] |
| 4. On-site assessment of a subsidiary | [F22£26,408] |
5. ‘For-cause’ review under Article 44(7) [F23of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746] to— (a) review assessments by the notified body, including clinical evaluation documentation; (b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 [F24, or Regulation (EU) 2017/746] or address a particular issue | (a) [F25£21,535] (b) [F26£26,408] |
Textual Amendments
F14Words 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)
F15Words 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)
F16Words 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)
F17Sum 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)
F18Words 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)
F19Sum 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)
F20Words 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)
F21Sum 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)
F22Sum 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)
F23Words 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)
F24Words 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)
F25Sum 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)
F26Sum 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)
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