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Regulation 54 Fees payable in connection with the designation of approved bodiesF37E1

England, Wales and Scotland

(1)

A corporate or other body that applies to the Secretary of State for designation under regulation 45 as F1an approved body shall, in connection with that application for designation, pay to the Secretary of State—

(a)

if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F2£10,335; or

(b)

in all other cases, a fee of F3£41,337.

F4(2)

A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) must, in connection with that application for a variation, pay to the Secretary of State—

(a)

in respect of an extension to the scope of the body’s designation to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated, a fee of F5£14,568;

(b)

in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain 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, a fee of F6£21,105.

(3)

Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F7both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of F8a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—

F9(a)

in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of F10£67,606 plus the amounts specified in paragraph (3A);

(F11b)

in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of F12£52,929, plus the amounts specified in paragraph (3A); and

(c)

in respect of an inspection pursuant to regulation 45(7)(b), a fee of F13£11,672 plus the amounts specified in paragraph (3A).

F14(3A)

Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—

(a)

an amount for time spent by a member of staff undertaking a site visit at a rate—

(i)

for the time spent on site, of F15£732 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

(ii)

for the time spent travelling to and from the site, of F16£198 per hour;

(b)

the actual costs of travel, accommodation and subsistence; and

(c)

out of pocket expenses.

(3B)

Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

(a)

the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

(b)

the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).

F17(3C)

F18An approved body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

(a)

a fee of F19£41,337 in respect of the application; and

(b)

where an audit is carried out in connection with the application, a fee of F20£67,606 in respect of the audit F21,

plus the amounts specified in paragraph (3A).

(3D)

Where the Secretary of State conducts an assessment of F22an approved body pursuant to article 5 of Regulation (EU) No 920/2013, F23the approved body shall pay to the Secretary of State—

(a)

if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of F24£21,535; or

(b)

in any other case, a fee of F25£26,408 F26,

plus the amounts specified in paragraph (3A).

(3E)

F27An approved body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of F28£1,503.

F29(3F)

Where, pursuant to regulation 45(7)(a) or 45(7)(b), the Secretary of State conducts an on-site assessment of a subsidiary of the body, the body must pay to the Secretary of State a fee of F30£26,408, plus the costs and expenses referred to in paragraph (3A).

(4)

A fee under this regulation—

(a)

in connection with an application for designation under F31regulation 45(1), a variation under regulation 45(4) F32, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012—

(i)

shall be payable when the application F33or submission to the Secretary of State is made, and

(ii)

shall accompany the application F34or submission when it is made;

(b)

in connection with an inspection pursuant to regulation 45(7) F35or an audit or assessment pursuant to Regulation (EU) No 920/2013, shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

F36(5)

In this regulation—

  • “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices; and

  • “subsidiary” is to be construed in accordance with section 1159 of the Companies Act 2006.

Annotations

Textual amendments

F1

Words in reg. 54(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F2

Sum in reg. 54(1)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(a)(i)

F3

Sum in reg. 54(1)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(a)(ii)

F4

Reg. 54(2) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(3)

F5

Sum in reg. 54(2)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(b)(i)

F6

Sum in reg. 54(2)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(b)(ii)

F7

Words in reg. 54(3) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 16

F8

Words in reg. 54(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F9

Reg. 54(3)(a)-(c) substituted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(2)(c)

F10

Sum in reg. 54(3)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(i)

F11

Reg. 54(3)(b) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(4)(b)

F12

Sum in reg. 54(3)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(ii)

F13

Sum in reg. 54(3)(c) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(iii)

F14

Reg. 54(3A)(3B) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(2)(d)

F15

Sum in reg. 54(3A)(a)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(d)(i)

F16

Sum in reg. 54(3A)(a)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(d)(ii)

F17

Reg. 54(3C)-(3E) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(6)

F18

Words in reg. 54(3C) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F19

Sum in reg. 54(3C)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(e)(i)

F20

Sum in reg. 54(3C)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(e)(ii)

F21

Words in reg. 54(3C) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(6)(c)

F22

Words in reg. 54(3D) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F23

Words in reg. 54(3D) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F24

Sum in reg. 54(3D)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(f)(i)

F25

Sum in reg. 54(3D)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(f)(ii)

F26

Words in reg. 54(3D) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(7)(c)

F27

Words in reg. 54(3E) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

F28

Sum in reg. 54(3E) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(g)

F29

Reg. 54(3F) inserted (E.W.S) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(9)

F30

Sum in reg. 54(3F) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(h)

F31

Words in reg. 54(4)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(i)

F32

Words in reg. 54(4)(a) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(ii)

F33

Words in reg. 54(4)(a)(i) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii)

F34

Words in reg. 54(4)(a)(ii) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii)

F35

Words in reg. 54(4)(b) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(b)

F36

Reg. 54(5) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(10)

F37

Reg. 54 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

Extent

E1

This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only