Regulation 9 Amendment of regulation 16 of the principal Regulations
In regulation 16 of the principal Regulations (procedures for general medical devices for clinical investigations) —
(a)
in paragraph (1)(a)—
“for “Sections 1 and 2” substitute “Sections 1 and 2.2”; and
(b)
after paragraph (10) add—
“(11)The manufacturer, or their single authorised representative, shall—
(a)notify the Secretary of State of the end of the clinical investigation; and
(b)provide justification where premature termination has resulted.”.