Statutory Instruments
2013 No. 525
Fees And Charges
The Medical Devices (Fees Amendment) Regulations 2013
Made
7th March 2013
Laid before Parliament
11th March 2013
Coming into force
1st April 2013
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.
Citation and commencement
1. These Regulations may be cited as the Medical Devices (Fees Amendment) Regulations 2013 and shall come into force on 1st April 2013.
Amendment of the Medical Devices Regulations 2002
2. —(1)Regulation 56 (fees payable in relation to clinical investigation notices) of the Medical Devices Regulations 2002( 4 ) is amended as follows.
(2) in paragraph (1)—
(a) in sub-paragraph (a), for “£2,120” substitute “£2,920” and for “£2,770” substitute “£3,570”;
(b) in sub-paragraph (b), for “£3,020” substitute “£3,820” and for “£4,240” substitute “£5,040”.
Signed by authority of the Secretary of State for Health.
Earl Howe
Parliamentary Under-Secretary of State,
Department of Health
1st March 2013
We consent
Desmond Swayne
Stephen Crabb
Two of the Lords Commissioners of Her Majesty’s Treasury
7th March 2013
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. 2002/618 ; relevant amendments have been made by S.I. 2003/1697 , 2007/803 , 2008/530 and 2009/383 .
OJ No. L189, 20.7.90, p.17 to which amendments have been made by Council Directive 93/42/EEC , (OJ No. L169, 12.7.93, p.1) Council Directive 93/68/EEC (OJ No. L220, 30.8.1993, p.1), Regulation http://www.legislation.gov.uk/legislation/european/regulation/2003/1882(EC) No. 1882/2003 of the European Parliament and Council (OJ No. L284, 31.10.03, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 331, 7.12.1998, p.1).
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 http://www.legislation.gov.uk/legislation/european/regulation/2003/1882 (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. L94, 4.4.2007, p.23).
OJ No. L331, 7.12.98, p.1 to which amendments have been made by Regulation http://www.legislation.gov.uk/legislation/european/regulation/2003/1882 (EC) No. 1882/2003 of the European Parliament and Council (OJ No.L284, 31.10.03, p.1), Regulation (EC) No. 596/2009 of the European Parliament and of the Council (OJ No. L188, 18.7.09, p.14) and Commission Directive 2011/100/EU (OJ No. L341, 22.12.11, p.50).