CEマーク
An example of such local implementation of the Directive is now present in Italy. Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14); however, in Italy it is applicable for all classes, not only Class I.