# The Active Implantable Medical Devices Regulations 1992, Paragraph 1


(1) The manufacturer shall make an application in writing for evaluation of his quality system to a notified body.
(2) The application shall be signed by or on behalf of the manufacturer and shall include—
(a) the information and undertakings which are required by paragraph 2 of Schedule 5 to be included in an application under paragraph 1 of that Schedule, other than the information required by paragraph 2(1)(e) of that Schedule so far as it relates to research and development and design;
(b) the technical documentation relating to the approved type and a copy of the EC type-examination certificate.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/8/paragraph/1 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-8/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.