Insertion of regulation 4(7D)
This section has no associated Explanatory Memorandum
20. 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”.”.