# The Active Implantable Medical Devices Regulations 1992, Paragraph 1: Statement


(1) The manufacturer or his authorised representative shall draw up for custom-made devices or for devices intended for clinical investigation a written statement in English comprising the particulars specified in sub-paragraph (1) or (2) respectively of paragraph 2.
(2) The statement shall be signed by or on behalf of the manufacturer or by his authorised representative.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/4/paragraph/1 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-4/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.