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Regulation 13 Amendment of regulation 29 of the principal Regulations

Original text. Later amendments are not shown.

In regulation 29 of the principal Regulations (procedures for active implantable medical devices for clinical investigations), after paragraph (9) add—

“(10)

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.”.