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 “£900” substitute “£930”; and

ii

in sub-paragraph (b), for “£3,600” substitute “£3,700”;

b

in paragraph (2), for “£1,800” substitute “£1,810”;

c

in paragraph (3)—

i

in sub-paragraph (a), for “£4,400” substitute “£4,500”;

ii

in sub-paragraph (b)(i), for “£7,200” substitute “£7,400”;

iii

in sub-paragraph (b)(ii), for “£5,400” substitute “£5,550”;

iv

in sub-paragraph (b)(iii), for “£3,600” substitute “£3,700”; and

v

in sub-paragraph (c), for “£3,600” substitute “£3,700”; and

d

in paragraph (3A)—

i

in sub-paragraph (a)(i), for “£254” substitute “£261”; and

ii

in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.

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 “£900” substitute “£930”; and

ii

in sub-paragraph (b), for “£3,600” substitute “£3,700”;

b

in paragraph (2), for “£1,800” substitute “£1,810”;

c

in paragraph (3)—

i

in sub-paragraph (a), for “£4,400” substitute “£4,500”;

ii

in sub-paragraph (b), for “£3,600” substitute “£3,700”;

iii

in sub-paragraph (c), for “£1,800” substitute “£1,810”; and

iv

in sub-paragraph (d), for “£3,600” substitute “£3,700”;

d

in paragraph (3A), for “£4,400” substitute “£4,500” and for “£1,800” substitute “£1,810”;

e

in paragraph (3B), for “£3,600” substitute “£3,700” and for “£1,800” substitute “£1,810”;

f

in paragraph (3C), for “£1,800” substitute “£1,810”; and

g

in paragraph (3D)—

i

in sub-paragraph (a)(i), for “£254” substitute “£261”; and

ii

in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.

4

In regulation 56 (fees payable in relation to clinical investigation notices), in paragraph (1)—

a

in sub-paragraph (a), for “£2,100” substitute “£2,120” and for “£2,700” substitute “£2,770”; and

b

in sub-paragraph (b), for “£3,000” substitute “£3,020” and for “£4,100” substitute “£4,240”.