
2010 No. 557
Fees And Charges
The Medical Devices (Fees Amendment) Regulations 2010
Made 25th February 2010
Laid before Parliament 4th March 2010
Coming into force 1st April 2010

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and section 56(1) and (2) of the Finance Act 1973.
The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medical devices.

The Treasury has consented to the making of these Regulations as required by section 56(1) of the Finance Act 1973.
Citation and commencement
1 
These Regulations may be cited as the Medical Devices (Fees Amendment) Regulations 2010 and shall come into force on 1st April 2010.
Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
2 

(1) The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 are amended as follows.
(2) In regulation 3 (fees)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£4,549” substitute “£4,595”; and
(ii) in sub-paragraph (b), for “£10,605” substitute “£10,711”;
(b) in paragraph (2)—
(i) in sub-paragraph (a), for “£900” substitute “£909”; and
(ii) in sub-paragraph (b), for “£2,517” substitute “£2,542”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,549” substitute “£4,595”; and
(ii) in sub-paragraph (b), for “£10,605” substitute “£10,711”;
(d) in paragraph (4)—
(i) in sub-paragraph (a), for “£900” substitute “£909”; and
(ii) in sub-paragraph (b), for “£2,517” substitute “£2,542”; and
(e) in paragraph (5)—
(i) in sub-paragraph (a), for “£46,531” substitute “£46,996”; and
(ii) in sub-paragraph (b), for “£11,552” substitute “£11,668”.
(3) In paragraph (2) of regulation 3A (fees for pre-consultation meetings)—
(a) in sub-paragraph (a), for “£824” substitute “£832”;
(b) in sub-paragraph (b), for “£1,044” substitute “£1,054”;
(c) in sub-paragraph (c), for “£1,428” substitute “£1,443”; and
(d) in sub-paragraph (d), for “£1,813” substitute “£1,831”.
Amendment of the Medical Devices Regulations 2002
3 

(1) The Medical Devices Regulations 2002 are amended as follows.
(2) In regulation 54 (fees payable in connection with the designation etc of notified bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£930” substitute “£960”; and
(ii) in sub-paragraph (b), for “£3,700” substitute “£3,840”;
(b) in paragraph (2), for “£1,810” substitute “£1,880”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,500” substitute “£4,670”;
(ii) in sub-paragraph (b)(i), for “£7,400” substitute “£7,670”;
(iii) in sub-paragraph (b)(ii), for “£5,550” substitute “£5,760”;
(iv) in sub-paragraph (b)(iii), for “£3,700” substitute “£3,840”; and
(v) in sub-paragraph (c), for “£3,700” substitute “£3,840”; and
(d) in paragraph (3A)—
(i) in sub-paragraph (a)(i), for “£261” substitute “£271”; and
(ii) in sub-paragraph (a)(ii), for “£72.56” substitute “£75.24”.
(3) In regulation 55 (fees payable in connection with the designation etc of conformity assessment bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£930” substitute “£960”; and
(ii) in sub-paragraph (b), for “£3,700” substitute “£3,840”;
(b) in paragraph (2), for “£1,810” substitute “£1,880”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,500” substitute “£4,670”;
(ii) in sub-paragraph (b), for “£3,700” substitute “£3,840”;
(iii) in sub-paragraph (c), for “£1,810” substitute “£1,880”; and
(iv) in sub-paragraph (d), for “£3,700” substitute “£3,840”;
(d) in paragraph (3A), for “£4,500” substitute “£4,670” and for “£1,810” substitute “£1,880”;
(e) in paragraph (3B), for “£3,700” substitute “£3,840” and for “£1,810” substitute “£1,880”;
(f) in paragraph (3C), for “£1,810” substitute “£1,880”; and
(g) in paragraph (3D)—
(i) in sub-paragraph (a)(i), for “£261” substitute “£271”; and
(ii) in sub-paragraph (a)(ii), for “£72.56” substitute “£75.24”.
Signed by authority of the Secretary of State for Health
Mike O’Brien
Minister of State,
Department of Health
22nd February 2010We consent
Tony Cunningham
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
25th February 2010