Il passaggio da PMC a dispositivi medici e la nuova normativa per l'immissione in commercio

The EU Directive concerning medical devices has been recently implemented in Italy (Law n. 46/97); according to this law the producer must guarantee the safety of the devices during utilization. Devices are divided in four classes on the basis of their potential risk. Modifications to the previous Italian situation are relevant. The preexisting Italian law concerned a wide variety of products included in a positive list divided in three main categories (chemical devices, in vitro diagnostic devices, medical devices) and imposed a pre-marketing authorization. In this paper problems concerning the new classification of the medical devices and the producer's duties and liability are discussed.