ANNEX IV EC DECLARATION OF CONFORMITY
(FULL QUALITY ASSURANCE SYSTEM)

4. Examination of the design of the product
4.1. For devices covered by Annex II, List A, in addition to the obligations imposed by section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the device which he plans to manufacture and which falls into the category referred to in section 3.1.