# The Active Implantable Medical Devices Regulations 1992, Paragraph 2


(1) Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.
(2) Subject to sub-paragraph (3) below, paragraphs 3(3) and (4)(a), (b), (d) and (e), 4 and 5 of Schedule 5 shall apply for the purposes of this Schedule as they apply for the purpoes of that Schedule, but as though any reference to paragraph 3(2) to (4) of that Schedule were a reference to sub-paragraph (1) of this paragraph and paragraphs 3(3) and (4)(a), (b), (d) and (e) of that Schedule.
(3) Paragraph 3(4)(b)(ii) of Schedule 5 shall not apply in respect of the desired quality of design.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/8/paragraph/2 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-8/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.