# The Active Implantable Medical Devices Regulations 1992, Paragraph 6: Design dossier


(1) A manufacturer who makes an application under paragraph 1 relating to a type of device shall also make an application for examination of the design dossier relating to that type of device which he plans to manufacture.
(2) The application shall describe the design, manufacture, and performances of the device in question and shall include the necessary particulars which make it possible to evaluate whether it complies with the requirements of the Directive.
(3) The particulars referred to in sub-paragraph (2) shall include the following:—
(a) the design specifications, including the Standards which have been applied;
(b) the necessary proof of their appropriateness, in particular where the relevant national Standards have not been applied in full, including the results of the appropriate tests carried out by the manufacturer or under his responsibility;
(c) a statement as to whether or not the device incorporates, as an integral part, a substance referred to in paragraph 10 of Schedule 2, whose action in combination with the device may result in its bioavailability, together with data on the relevant tests conducted;
(d) the clinical data referred to in Schedule 3;
(e) the draft instruction leaflet.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/5/paragraph/6 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-5/paragraph-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.