SCHEDULE 1Amendment of the Medical Devices Regulations 2002

Amendment of regulation 4919

In regulation 49 (fees charged by UK notified bodies and EC conformity assessment bodies)—

a

for the heading substitute “Fees charged by UK notified bodies and conformity assessment bodies”;

b

in the opening words of paragraph (1) for “EC CAB” substitute “CAB”;

c

in paragraph (1)(a) for “the Medical Devices Directives or the Mutual Recognition Agreements in respect of a conformity assessment procedure set out in the Medical Devices Directives” substitute “the Medical Devices Directives or a UK mutual recognition agreement in respect of a conformity assessment procedure set out in the Medical Devices Directives or these Regulations as they apply in Great Britain”;

d

in paragraph (1)(b)—

i

for “an EC CAB” in both places substitute “a CAB”;

ii

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

e

in paragraph (3) for “EC CAB” substitute “CAB”;

f

in paragraph (4) for “EC CAB” substitute “CAB”.