PART 1Amendment of the 2002 Regulations

Amendment of Part VI of the 2002 RegulationsI18

1

Part VI of the 2002 Regulations is amended as follows.

I2F22

In regulation 53 (fees in connection with the registration of devices and changes in registration details) for “regulation 19 or 44” substitute “regulation 7A, 19, 21A, 33A or 44”.

3

In regulation 54 (fees payable in connection with the designation of UK notified bodies)—

a

for the heading substitute “Fees payable in connection with the designation of approved bodies”;

b

in paragraph (1) for “a notified body” substitute “an approved body”;

c

in paragraph (3) for “the Mutual Recognition Agreements” in both places substitute “a mutual recognition agreement”;

d

in paragraph (3C) for “A UK notified body” substitute “An approved body”;

e

in paragraph (3D)—

i

for “a UK notified body” substitute “an approved body”;

ii

for “the UK notified body” substitute “the approved body”;

f

in paragraph (3E) for “A UK notified body” substitute “An approved body”.

F34

In regulation 55 (fees payable in connection with the designation etc. of EC conformity assessment bodies)—

a

in the heading omit “EC”;

b

in paragraph (1), for “an EC CAB” substitute “ a CAB ”;

c

in paragraph (3)—

i

for “an EC CAB” substitute “ a CAB ”;

ii

for “the Mutual Recognition Agreements” substitute “ a mutual recognition agreement ”.

F14A

In regulation 56 (fees payable in relation to clinical investigation notices), in paragraph (2), for “his authorised representative” substitute “their UK responsible person”.

F45

In regulation 58 (waivers, reductions and refunds)—

a

in paragraph (2)(b)(i) for “a notified body” substitute “an approved body”;

b

in paragraph (2)(b)(ii) for “an EC CAB” substitute “a CAB”.