2010 No. 557
The Medical Devices (Fees Amendment) Regulations 2010
Made
Laid before Parliament
Coming into force
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 19721 and section 56(1) and (2) of the Finance Act 19732.
The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 19723 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 commencement1
These Regulations may be cited as the Medical Devices (Fees Amendment) Regulations 2010 and shall come into force on 1st April 2010.
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 “£4,549” substitute “£4,595”; and
ii
in sub-paragraph (b), for “£10,605” substitute “£10,711”;
b
in paragraph (2)—
i
in sub-paragraph (a), for “£900” substitute “£909”; and
ii
in sub-paragraph (b), for “£2,517” substitute “£2,542”;
c
in paragraph (3)—
i
in sub-paragraph (a), for “£4,549” substitute “£4,595”; and
ii
in sub-paragraph (b), for “£10,605” substitute “£10,711”;
d
in paragraph (4)—
i
in sub-paragraph (a), for “£900” substitute “£909”; and
ii
in sub-paragraph (b), for “£2,517” substitute “£2,542”; and
e
in paragraph (5)—
i
in sub-paragraph (a), for “£46,531” substitute “£46,996”; and
ii
in sub-paragraph (b), for “£11,552” substitute “£11,668”.
3
In paragraph (2) of regulation 3A (fees for pre-consultation meetings)—
a
in sub-paragraph (a), for “£824” substitute “£832”;
b
in sub-paragraph (b), for “£1,044” substitute “£1,054”;
c
in sub-paragraph (c), for “£1,428” substitute “£1,443”; and
d
in sub-paragraph (d), for “£1,813” substitute “£1,831”.
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 notified bodies)—
a
in paragraph (1)—
i
in sub-paragraph (a), for “£930” substitute “£960”; and
ii
in sub-paragraph (b), for “£3,700” substitute “£3,840”;
b
in paragraph (2), for “£1,810” substitute “£1,880”;
c
in paragraph (3)—
i
in sub-paragraph (a), for “£4,500” substitute “£4,670”;
ii
in sub-paragraph (b)(i), for “£7,400” substitute “£7,670”;
iii
in sub-paragraph (b)(ii), for “£5,550” substitute “£5,760”;
iv
in sub-paragraph (b)(iii), for “£3,700” substitute “£3,840”; and
v
in sub-paragraph (c), for “£3,700” substitute “£3,840”; and
d
in paragraph (3A)—
i
in sub-paragraph (a)(i), for “£261” substitute “£271”; and
ii
in sub-paragraph (a)(ii), for “£72.56” substitute “£75.24”.
3
In regulation 55 (fees payable in connection with the designation etc of conformity assessment bodies)—
a
in paragraph (1)—
i
in sub-paragraph (a), for “£930” substitute “£960”; and
ii
in sub-paragraph (b), for “£3,700” substitute “£3,840”;
b
in paragraph (2), for “£1,810” substitute “£1,880”;
c
in paragraph (3)—
i
in sub-paragraph (a), for “£4,500” substitute “£4,670”;
ii
in sub-paragraph (b), for “£3,700” substitute “£3,840”;
iii
in sub-paragraph (c), for “£1,810” substitute “£1,880”; and
iv
in sub-paragraph (d), for “£3,700” substitute “£3,840”;
d
in paragraph (3A), for “£4,500” substitute “£4,670” and for “£1,810” substitute “£1,880”;
e
in paragraph (3B), for “£3,700” substitute “£3,840” and for “£1,810” substitute “£1,880”;
f
in paragraph (3C), for “£1,810” substitute “£1,880”; and
g
in paragraph (3D)—
i
in sub-paragraph (a)(i), for “£261” substitute “£271”; and
ii
in sub-paragraph (a)(ii), for “£72.56” substitute “£75.24”.
Signed by authority of the Secretary of State for Health
We consent
(This note is not part of the Regulations)