Paragraph 31 Insertion of regulation 5(5C)

After regulation 5(5B) insert—

“(5C)

In regulation 29 (procedures for active implantable medical devices for clinical investigations)—

(a)

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

(b)

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

(c)

in paragraph (3), for “or authorised representative” substitute “or UK responsible person”;

(d)

in paragraph (10) for “single authorised representative” substitute “single UK responsible person”.”.