# The Medical Devices Regulations 1994, Regulation 16: Clinical investigations


(1) Before devices intended for clinical investigation are made available to a medical practitioner or authorised qualified person 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—
(a) the statement required by Sections 1, 2 and 2.2 of Annex VIII; and
(b) the undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII.
(2) If, within 60 days of the giving of that notice, the Secretary of State gives written notice to the manufacturer or authorised representative, whichever gave the notice to her under paragraph (1), that, on grounds of public health or public policy, devices should not be made available for the purposes of that investigation, devices may not be made available for those purposes pursuant to that notice under paragraph (1).
(3) Where the relevant ethics committee has issued a favourable opinion on a programme of clinical investigation, the Secretary of State may give written notice to the manufacturer or his authorised representative within 60 days of the giving of notice under paragraph (1) that devices may be made available for the purposes of that investigation at any time after the giving of notice under that paragraph.
(4) The manufacturer of a device intended for clinical investigation shall—
(a) 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 the first paragraph of Section 3.2 of Annex VIII; and
(b) authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.
(5) The manufacturer or his authorised representative shall—
(a) keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X; and
(b) keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of 5 years.
(6) Clinical investigations shall be conducted in accordance with the provisions of Annex X.
(7) Paragraphs (1), (2) and (3) do not apply where clinical investigations are conducted using devices which are authorised in accordance with regulation 7, 8, 9 or 10 to bear the CE marking unless the aim of those investigations is to determine whether the device in question may be used for a purpose other than that referred to in the relevant conformity assessment procedure.
(8) 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 assessment by the Secretary of State, whether by means of an audit, and inspection or otherwise, of the effectiveness of the measures referred to in paragraph (4); or
(b) the manufacturer or his authorised representative does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/16 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.