Directive 98/79/EC of the European Parliament and of the CouncilDangos y teitl llawn

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

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.U.K.