Statutory Instruments
2008 No. 530
Fees And Charges
The Medical Devices (Fees Amendments) Regulations 2008
Made
27th February 2008
Laid before Parliament
6th March 2008
Coming into force
1st April 2008
The Secretary of State for Health, in exercise of the powers conferred on him by section 2(2) of the European Communities Act 1972( 1 ) and section 56(1) and (2) of the Finance Act 1973( 2 ), hereby makes the following regulations.
The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972( 3 ) in relation to medicinal products and 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 2008 and shall come into force on 1 st April 2008.
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 “£4,141” substitute “”£4,374”, and
(ii) in sub-paragraph (b), for “£9,653” substitute “£10,197”;
(b) in paragraph (2)—
(i) in sub-paragraph (a), for “£819” substitute “£865”, and
(ii) in sub-paragraph (b), for “£2,291” substitute “£2,420”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,141” substitute “£4,374”, and
(ii) in sub-paragraph (b), for “”£9,653” substitute “£10,197”;
(d) in paragraph (4)—
(i) in sub-paragraph (a), for “£819” substitute “£865”, and
(ii) in sub-paragraph (b), for “£2,291” substitute “ £2,420”;
(e) in paragraph (5)—
(i) in sub-paragraph (a), for “£42,352” substitute “£44,741”, and
(ii) in sub-paragraph (b), for “£10,515” substitute “£11,108”.
(3) In paragraph (2) of regulation 3A (fees for pre-consultation meetings)—
(a) in sub-paragraph (a), for “£750” substitute “£792”;
(b) in sub-paragraph (b), for “£950” substitute “£1,004”;
(c) in sub-paragraph (c) for “£1,300” substitute £1,373”; and
(d) for “(a) if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, £1,650” substitute—
“ (d) if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, £1,173 ” .
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 “£850” substitute “£900”, and
(ii) in sub-paragraph (b), for “£3,400” substitute “£3,600”;
(b) in paragraph (2), for “£1,700” substitute “£1,800”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,200” substitute “£4,400”,
(ii) in sub-paragraph (b)(i), for “£6,800” substitute “£7,200”,
(iii) in sub-paragraph (b)(ii), for “£5,100” substitute “£5,400”,
(iv) in sub-paragraph (b)(iii), for “£3,400” substitute “£3,600”; and
(v) in sub-paragraph (c), for “£3,400” substitute “£3,600”; and
(d) in paragraph (3A)—
(i) in sub-paragraph (a)(i), for “£240” substitute “£254”, and
(ii) in sub-paragraph (a) (ii), for “£67.10” substitute “£70.45”.
(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 “£850” substitute £900”, and
(ii) in sub-paragraph (b), for “£3,400” substitute “£3,600”;
(b) in paragraph (2), for “£1,700” substitute “£1,800”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,200” substitute “£4,400”,
(ii) in sub-paragraph (b), for “£3,400” substitute “£3,600”,
(iii) in sub-paragraph (c), for “£1,700” substitute “£1,800”, and
(iv) in sub-paragraph (d), for “£3,400” substitute “£3,600”;
(d) in paragraph (3A), for “£4,200” substitute “£4,400” and for “£1,700” substitute “£1,800”;
(e) in paragraph (3B), for “£3,400” substitute “£3,600” and for “£1,700” substitute “£1,800”;
(f) in paragraph (3C), for “£1,700” substitute “£1,800”; and
(g) in paragraph (3D)—
(i) in sub-paragraph (a)(i), for “£240” substitute “£254”, and
(ii) in sub-paragraph (a) (ii), for “£67.10” substitute “£70.45”.
(4) In regulation 56 (fees payable in relation to clinical investigations), in paragraph (1)-
(a) in sub-paragraph (a)—
(i) in sub-paragraph (i), for “£1,800” substitute “£2,100”, and
(ii) in sub-paragraph (ii), for “£2,400” substitute “£2,700”; and
(b) in sub-paragraph (b)—
(i) in sub-paragraph (i), for “£2,700”substitute “£3,000”, and
(ii) in sub-paragraph (ii), for “£3,800” substitute “£4,100”.
Signed by authority of the Secretary of State.
Dawn Primarolo
Minister of State,
Department of Health
27th February 2008
We consent
Alan Campbell
Steve McCabe
Two of the Lords Commissioners of her Majesty’s Treasury
26th February 2008
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. 1993/2651 .
S.I. 1995/449 ; relevant amending instrument is S.I. 2007/803 .
S.I. 2002/618 ; relevant amendments have been made by S.I. 2003/1697 and S.I. 2007/803 .
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. L 6, 10.1.2002, p. 50 and Directive 2007/47/EC of the European Parliament and of the Council , OJ No L 247, 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. L 220, 30.8.1993, p.1 and Directive 2007/47/EC .
OJ No. L331, 7.12.98, p.1.