PART 2 Amendment of the Medical Devices Regulations 2002

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

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.