Consumer Protection Citation, commencement and interpretation 1 1 These Regulations may be cited as the Medical Devices (Fees Amendment) Regulations 2017 and shall come into force on 1st April 2017. 2 In these Regulations, “the 2002 Regulations” means the Medical Devices Regulations 2002 . Amendment of regulation 53 of the 2002 Regulations 2 In regulation 53 of the 2002 Regulations (fees in connection with the registration of devices and changes to registration details), for “£70” substitute “£100”. Amendment of regulation 54 of the 2002 Regulations 3 1 Regulation 54 of the 2002 Regulations (fees payable in connection with the designation etc. of UK notified bodies) is amended as follows. 2 In paragraph (1)— a in sub-paragraph (a), for “£960” substitute “£2,063”; and b in sub-paragraph (b), for “£3,840”substitute “£8,252”. 3 In paragraph (2), for “£1,880” substitute “£6,504”. 4 In paragraph (3)— a in sub-paragraph (a), for “£4,670” substitute “£15,904”; b in sub-paragraph (b), for each of “£7,670”, “£5,760” and “£3,840” substitute “£10,160”; and c in sub-paragraph (c), for “£3,840” substitute “£4,404”. 5 In paragraph (3A)— a in sub-paragraph (a)(i), for “£271” substitute “£361.20”; and b in sub-paragraph (a)(ii), for “£75.24” substitute “£90.30”. 6 After paragraph (3B) insert— 3C A UK notified 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 £8,252 in respect of the application; and b where an audit is carried out in connection with the application, a fee of £15,904 in respect of the audit. 3D Where the Secretary of State conducts an assessment of a UK notified body pursuant to article 5 of Regulation (EU) No 920/2013, the UK notified 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 £2,586; or b in any other case, a fee of £3,876. 3E A UK notified 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 £532. . 7 In paragraph (4)— a in sub-paragraph (a)— i for “regulation 45(1) or” substitute “regulation 45(1),”, ii after “regulation 45(4)” insert “, 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”, and iii in paragraphs (i) and (ii), after “application” insert “or submission”; and b in sub-paragraph (b), after “regulation 45(7)” insert “or an audit or assessment pursuant to Regulation (EU) No 920/2013”. 8 After paragraph (4), insert— 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 . . Amendment of regulation 55 of the 2002 Regulations 4 1 Regulation 55 of the 2002 Regulations (fees payable in connection with the designation etc. of EC conformity assessment bodies) is amended as follows. 2 In paragraph (1)— a in sub-paragraph (a), for “£960” substitute “£2,063”; and b in sub-paragraph (b), for “£3,840”substitute “£8,252”. 3 In paragraph (2), for “£1,880” substitute “£6,504”. 4 In paragraph (3)— a in sub-paragraph (a), for “£4,670” substitute “£15,904”; b in sub-paragraph (b), for “£3,840” substitute “£4,404”; and c in sub-paragraph (d), for “£3,840” substitute “£4,404”. 5 In paragraph (3A), for “£4,670” substitute “£15,904”. 6 In paragraph (3B), for “£3,840” substitute “£4,404”. 7 In paragraph (3D)— a in sub-paragraph (a)(i), for “£271” substitute “£361.20”; and b in sub-paragraph (a)(ii), for “£75.24” substitute “£90.30”. Amendment of regulation 56 of the 2002 Regulations 5 1 Regulation 56 of the 2002 Regulations (fees payable in relation to clinical investigation notices) is amended as follows. 2 In paragraph (2), after “paragraph (3)” insert “or (3A)”. 3 After paragraph (3) insert— 3A Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State— a a fee, if the device is a Group A device, of £207; or b a fee, if the device is a Group B device, of £331. . Signed by authority of the Secretary of State for Health. O’Shaughnessy Parliamentary Under-Secretary of State Department of Health 23rd February 2017 We consent Guto Bebb Robert Syms Two of the Lords Commissioners of Her Majesty’s Treasury 24th February 2017