The Medical Devices Regulations 2002

Fees payable in connection with the designation etc. of EC conformity assessment bodies U.K.

55.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as an EC 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 [F1 £930]; or

(b) in all other cases, a fee of [F2 £3,700].

(2) A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of [F3 £1,810].

(3) [F4 Subject 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 an EC CAB arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F5 (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 [F6 £4,500] 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 [F7 £3,700] 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 [F8 £1,810];

(d) in respect of an inspection pursuant to regulation 48(7)(b), a fee of [F9 £3,700] plus the amounts specified in paragraph (3D).]

[F10 (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 [F11 £4,500] plus—

(a) [F11 £1,810] 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 [F12 £3,700] plus—

(a) [F12 £1,810] 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 [F13 £1,810] 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 [F14 £261] 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 [F15 £72.56] 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.

Textual Amendments

F1 Word in reg. 55(1)(a) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(a)(i)

F2 Word in reg. 55(1)(b) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(a)(ii)

F3 Word in reg. 55(2) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(b)

F4 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)

F5 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)

F6 Word in reg. 55(3)(a) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(c)(i)

F7 Word in reg. 55(3)(b) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(c)(ii)

F8 Word in reg. 55(3)(c) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(c)(iii)

F9 Word in reg. 55(3)(d) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(c)(iv)

F10 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)

F11 Words in reg. 55(3A) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(d)

F12 Words in reg. 55(3B) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(e)

F13 Word in reg. 55(3C) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(f)

F14 Word in reg. 55(3D)(a)(i) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(g)(i)

F15 Word in reg. 55(3D)(a)(ii) substituted (1.4.2009) by The Medical Devices (Fees Amendments) Regulations 2009 (S.I. 2009/383), regs. 1, 3(3)(g)(ii)