Paragraph 20 Insertion of regulation 4(7D)

After regulation 4(7C) insert—

“(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”.”.