# The Active Implantable Medical Devices Regulations 1992, Paragraph 8: Design examination certificate


(1) An applicant to whom an EC design examination certificate has been issued shall inform the relevant notified body of any modification made to the approved design.
(2) Any such modification must receive approval from the relevant notified body where it may affect conformity with the relevant essential requirements or the conditions prescribed for the use of the type of device.
(3) Any supplementary approval which is given shall be given in the form of an addendum to the EC design examination certificate.
(4) In this paragraph and paragraph 9 “relevant notified body” in relation to a design means the notified body which issued the EC design examination certificate in respect of it, except that where that body is no longer a notified body as respects tasks under this paragraph it means such other notified body as the Secretary of State shall have designated as the notified body in relation to those tasks and that design.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/5/paragraph/8 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-5/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.