# The Medical Devices Regulations 1994, Regulation 15: Custom-made devices


(1) Before a custom-made device is placed on the market its manufacturer shall—
(a) draw up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII;
(b) undertake to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations; and
(c) take all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII.
(2) The information contained in the statement referred to in paragraph (1)(a) and in the undertaking referred to in paragraph (1)(b) shall be kept available for a minimum period of 5 years.

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/15 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.