# The Active Implantable Medical Devices Regulations 1992, Regulation 7: Clinical investigations


(1) Before devices intended for clinical investigation are made available to a medical specialist for the purposes of a clinical investigation to take place within the United Kingdom their manufacturer or his authorised representative shall give at least 60 days' prior notice in writing to the Secretary of State of the making available of the devices for the intended investigation, in the form of the statement provided for by paragraphs 1 and 2(2) of Schedule 4 and the undertaking by the manufacturer mentioned in paragraph 3 of that Schedule.
(2) If, within 60 days of the giving of that notice, the Secretary of State gives written notice to the manufacturer or his authorised representative, whichever gave the notice to him under paragraph (1), that, on grounds relating to the health or safety of patients, users or others, devices should not be made available for the purposes of those investigations, devices may not be made available for those purposes pursuant to that notice under paragraph (1).
(3) The manufacturer of a device intended for clinical investigation shall take all necessary measures to ensure that the manufacturing process ensures that a device manufactured according to that process conforms to the documentation referred to in paragraph 3(b) of Schedule 4 and may authorise the evaluation, by audit where necessary, of the effectiveness of the measures which he takes pursuant to Schedule 4.
(4) A manufacturer who has given the undertaking mentioned in paragraph (1) shall, if so required by the Secretary of State for the purposes of his functions under paragraph (2), make available to him the documentation which he has undertaken to keep available.
(5) The grounds on which a notice may be given under paragraph (2) include the grounds that the Secretary of State is not satisfied as to the safety of a device for the intended purposes because—
(a) the manufacturer does not authorise an evaluation by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (3); or
(b) the manufacturer does not make available to the Secretary of State documenta tion which he has undertaken to keep available.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/regulation/7 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/regulation-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.