Statutory Instruments
2009 No. 383
Fees And Charges
The Medical Devices (Fees Amendments) Regulations 2009
Made
23rd February 2009
Laid before Parliament
3rd March 2009
Coming into force
1st April 2009
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 Amendments) Regulations 2009 and shall come into force on 1st April 2009.
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 “£4,374” substitute “£4,549”; and
(ii) in sub-paragraph (b), for “£10,197” substitute “£10,605”;
(b) in paragraph (2)—
(i) in sub-paragraph (a), for “£865” substitute “£900”; and
(ii) in sub-paragraph (b), for “£2,420” substitute “£2,517”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,374” substitute “£4,549”; and
(ii) in sub-paragraph (b), for “£10,197” substitute “£10,605”;
(d) in paragraph (4)—
(i) in sub-paragraph (a), for “£865” substitute “£900”; and
(ii) in sub-paragraph (b), for “£2,420” substitute “£2,517”; and
(e) in paragraph (5)—
(i) in sub-paragraph (a), for “£44,741” substitute “£46,531”; and
(ii) in sub-paragraph (b), for “£11,108” substitute “£11,552”.
(3) In paragraph (2) of regulation 3A (fees for pre-consultation meetings)—
(a) in sub-paragraph (a), for “£792” substitute “£824”;
(b) in sub-paragraph (b), for “£1,004” substitute “£1,044”;
(c) in sub-paragraph (c), for “£1,373” substitute “£1,428”; and
(d) in sub-paragraph (d), for “£1,173” substitute “£1,813”.
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 UK notified bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£900” substitute “£930”; and
(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;
(b) in paragraph (2), for “£1,800” substitute “£1,810”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,400” substitute “£4,500”;
(ii) in sub-paragraph (b)(i), for “£7,200” substitute “£7,400”;
(iii) in sub-paragraph (b)(ii), for “£5,400” substitute “£5,550”;
(iv) in sub-paragraph (b)(iii), for “£3,600” substitute “£3,700”; and
(v) in sub-paragraph (c), for “£3,600” substitute “£3,700”; and
(d) in paragraph (3A)—
(i) in sub-paragraph (a)(i), for “£254” substitute “£261”; and
(ii) in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.
(3) In regulation 55 (fees payable in connection with the designation etc of EC conformity assessment bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£900” substitute “£930”; and
(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;
(b) in paragraph (2), for “£1,800” substitute “£1,810”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,400” substitute “£4,500”;
(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;
(iii) in sub-paragraph (c), for “£1,800” substitute “£1,810”; and
(iv) in sub-paragraph (d), for “£3,600” substitute “£3,700”;
(d) in paragraph (3A), for “£4,400” substitute “£4,500” and for “£1,800” substitute “£1,810”;
(e) in paragraph (3B), for “£3,600” substitute “£3,700” and for “£1,800” substitute “£1,810”;
(f) in paragraph (3C), for “£1,800” substitute “£1,810”; and
(g) in paragraph (3D)—
(i) in sub-paragraph (a)(i), for “£254” substitute “£261”; and
(ii) in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.
(4) In regulation 56 (fees payable in relation to clinical investigation notices), in paragraph (1)—
(a) in sub-paragraph (a), for “£2,100” substitute “£2,120” and for “£2,700” substitute “£2,770”; and
(b) in sub-paragraph (b), for “£3,000” substitute “£3,020” and for “£4,100” substitute “£4,240”.
Signed by authority of the Secretary of State for Health.
Dawn Primarolo
Minister of State,
Department of Health
9th February 2009
We consent
Tony Cunningham
Dave Watts
Two of the Lords Commissioners of Her Majesty’s Treasury
23rd February 2009
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 Community 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 and 2008/530 .
S.I. 2002/618 ; relevant amendments have been made by S.I. 2003/1697 , 2007/803 and 2008/530 .
OJ No. L169, 12.7.93, p.1 to which amendments have been made by Directive 2000/70/EC of the European Parliament and of the Council, OJ No. L 313, 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 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 93/68/EEC , OJ No. L220, 30.8.1993, p.1 and Directive 2007/47/EC .
OJ No. L331, 7.12.98, p.1.