Statutory Instruments
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( 1 ) and section 56(1) and (2) of the Finance Act 1973( 2 ).
The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972( 3 ) 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( 4 ) 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( 5 ) 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 2010
We consent
Tony Cunningham
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
25th February 2010
1972 c.68 . Under section 57(1) of the Scotland Act 1998 (c.46) , despite the transfer to Scottish Ministers of functions in relation to implementing obligations under European Union law in relation to devolved matters, the functions of the Secretary of State in relation to implementing these obligations continues to be exercisable by the Secretary of State as regards Scotland.
The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289 and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661 .
S.I. 1995/449 ; relevant amending instruments are S.I. 2007/803 , 2008/530 and 2009/383 .
S.I. 2002/618 ; relevant amendments have been made by S.I. 2003/1697 , 2007/803 , 2008/530 and 2009/383 .
OJ No. L169, 12.7.93, p.1 to which amendments have been made by Directive 98/79/EC of the European Parliament and of the Council (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L313, 13.12.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L6, 10.1.2002, p.50), Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L284, 31.10.2003, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L247, 21.9.2007, p.21).
OJ No. L189, 20.7.90, p.17 to which amendments have been made by Council Directive 93/42/EEC , Council Directive 93/68/EEC (OJ No. L220, 30.8.1993, p.1), Regulation (EC) No. 1882/2003 and Directive 2007/47/EC .
OJ No. L331, 7.12.98, p.1 to which amendments have been made by Regulation (EC) No. 1882/2003 .