OpenLegislation

Regulation 55 Fees payable in connection with the designation etc. of ... conformity assessment bodiesF23E1

England, Wales and Scotland

(1)

A corporate or other body that applies to the Secretary of State for designation under regulation 48 as F1a CAB 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 48(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 arising out of a mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of F5£14,568; or

(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 which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of F6£21,105.

(3)

F7Subject to paragraphs (3A) to (3C) where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of F8a CAB arising out of F9a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—

F10(a)

in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of F11£67,606 plus the amounts specified in paragraph (3D);

(b)

in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of F12£11,672 plus the amounts specified in paragraph (3D);

(c)

in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of F13£1,880;

(d)

in respect of an inspection pursuant to regulation 48(7)(b), a fee of F14£11,672 plus the amounts specified in paragraph (3D).

F15(3A)

Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be F16£67,606 plus—

(a)

F17£1,880 for each additional inspection; and

(b)

the amounts specified in paragraph (3D).

(3B)

Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be F18£11,672 plus—

(a)

F19£1,880 for each additional inspection; and

(b)

the amounts specified in paragraph (3D)

(3C)

Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be F20£1,880 for each inspection.

(3D)

The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) 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 F21£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 F22£198 per hour;

(b)

the actual costs of travel, accommodation and subsistence, and

(c)

out of pocket expenses.

(4)

A fee under this regulation—

(a)

in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—

(i)

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

(ii)

shall accompany the application when it is made;

(b)

in connection with an inspection pursuant to regulation 48(7), 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.

Annotations

Textual amendments

F1

Words in reg. 55(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(4)(b) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

F2

Sum in reg. 55(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), 6(a)(i)

F3

Sum in reg. 55(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), 6(a)(ii)

F4

Reg. 55(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), 11(3)

F5

Sum in reg. 55(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), 6(b)(i)

F6

Sum in reg. 55(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), 6(b)(ii)

F7

Words in reg. 55(3) 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(3)(c)(i)

F8

Words in reg. 55(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(4)(c)(i) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

F9

Words in reg. 55(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(4)(c)(Ii) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

F10

Reg. 55(3)(a)-(d) substituted for reg. 55(3)(a)-(c) (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(3)(c)(ii)

F11

Sum in reg. 55(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), 6(c)(i)

F12

Sum in reg. 55(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), 6(c)(ii)

F13

Sum in reg. 55(3)(c) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(c)(iii)

F14

Sum in reg. 55(3)(d) 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), 6(c)(ii)

F15

Reg. 55(3A)-(3D) 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(3)(d)

F16

Sum in reg. 55(3A) 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), 6(d)

F17

Sums in reg. 55(3A) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(d)

F18

Sum in reg. 55(3B) 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), 6(e)

F19

Sums in reg. 55(3B) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(e)

F20

Sum in reg. 55(3C) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(f)

F21

Sum in reg. 55(3D)(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), 6(f)(i)

F22

Sum in reg. 55(3D)(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), 6(f)(ii)

F23

Word in reg. 55 heading omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(a) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 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