# The Medical Devices (Amendment) Regulations 2008, 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.”.

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Source: https://www.legislation.gov.uk/uksi/2008/2936/regulation/9 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-regulations-2008/regulation-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.