SCHEDULE 1Amendment of the Medical Devices Regulations 2002

Amendment of regulation 6023

In regulation 60 (designation etc of authorised representatives)—

a

in paragraph (1)—

i

omit “, other than an obligation referred to in regulation 17(3),”;

ii

for “in the Community or (where appropriate) in a State which is a Party to an Association Agreement” substitute “in a relevant state”;

b

in paragraph (2)—

i

for “in the Community or (where appropriate) in a State which is a Party to an Association Agreement” substitute “in a relevant state”;

ii

in sub-paragraph (a) for “in the Community” substitute “in a relevant state”;

c

in paragraph (3)—

i

for “the Community” substitute “a relevant state”;

ii

in sub-paragraph (b)—

aa

for “the United Kingdom” substitute “Northern Ireland”;

bb

for “the Community or in a State which is a Party to an Association Agreement” substitute “a relevant state”.