2008 No. 530

Fees And Charges

The Medical Devices (Fees Amendments) Regulations 2008

Made

Laid before Parliament

Coming into force

The Secretary of State for Health, in exercise of the powers conferred on him by section 2(2) of the European Communities Act 19721 and section 56(1) and (2) of the Finance Act 19732, hereby makes the following regulations.

The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 19723 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 commencement1

These Regulations may be cited as The Medical Devices (Fees Amendments) Regulations 2008 and shall come into force on 1st April 2008.

Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 19952

1

The Medical Devices (Consultation Requirements) (Fees) Regulations 19954 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 20023

1

The Medical Devices Regulations 20025 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 PrimaroloMinister of State,Department of Health

We consent

Alan CampbellSteve McCabeTwo of the Lords Commissioners of her Majesty’s Treasury
EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make amendments to the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 and the Medical Devices Regulations 2002.

The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC concerning medical devices6. Regulation 2 of these Regulations amends the 1995 Regulations by increasing the amounts of the fees specified in regulations 3 and 3A of those Regulations (overall average increase of 6%).

The Medical Devices Regulations 2002 contain the legislative measures necessary for the implementation of the European Community scheme for regulating the placing on the market and putting into service of medical devices, set out in Council Directive 90/385/EEC on the approximation of the laws of Member States relating to active implantable medical devices 7, Council Directive 93/42/EEC concerning medical devices and Council Directive 98/79/EC on in vitro diagnostic devices8.Regulation 3 of these Regulations amends regulations 54 to 56 of the Medical Devices Regulations 2002, which provide for the fees payable in connection with the designation etc of UK notified bodies and EC conformity assessment bodies and the fees payable in relation to clinical investigation notices. The overall increase in fees is 6%.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ and copies have been placed in the libraries of both Houses of Parliament.