La directive vise à compléter la législation existante applicable aux dispositifs médicaux, à savoir la directive 93/42/CEE, en prévoyant des règles spécifiques pour les dispositifs de diagnostic in vitro, qui étaient exclus de cette directive.
The purpose of the Directive is to complete the existing body of legislation applicable to medical devices, viz. Directive 93/42/EEC, by providing for specific rules for in vitro diagnostic devices which were excluded from that Directive.