2008 No. 530
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.
We consent
(This note is not part of the Regulations)