The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023

Amendment of regulation 56 in relation to England, Scotland and Wales (fees payable in relation to clinical investigation notices)

This section has no associated Explanatory Memorandum

13.—(1) In regulation 56(1)(1)—

(a)in sub-paragraph (a)(i), for “£2,920” substitute “£5,711”,

(b)in sub-paragraph (a)(ii), for “£3,570” substitute “£11,069”,

(c)in sub-paragraph (b)(i), for “£3,820” substitute “£7,472”, and

(d)in sub-paragraph (b)(ii), for “£5,040” substitute “£15,627”.

(2) After regulation 56(3A), insert—

(3B) A person who requests a meeting with the Secretary of State in respect of an intended clinical investigation under regulation 16(1A) or 29(1A) must pay the following fees in advance of the meeting—

(a)£906 for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); and

(b)£782 for a statistical review meeting under regulation 16(1A)(b) or 29(1A)(b)..

(1)

Amended by S.I. 2019/791.