7D

In regulation 16 (procedures for general medical devices for clinical investigation)—

a

for “his authorised representative” each time those words occur, substitute “their UK responsible person”;

b

in paragraph (1), for “the United Kingdom” substitute “Great Britain”;

c

in paragraph (2)—

i

for “CE marking” substitute “UK marking”;

ii

for “CE marked” substitute “UK marked”;

d

in paragraph (4) for “or authorised representative” substitute “or UK responsible person”;

e

in paragraph (11) for “single authorised representative” substitute “single UK responsible person”.