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”.