Registration of in vitro diagnostic medical devices in the national database

Regulation (EU) 2017/746 (IVDR) provides, in Articles 26 and 28 respectively, for the registration of devices and economic operators in the European database Eudamed.

Waiting for the functionality of the modules of Eudamed dedicated to the registration of economic operators, devices and related certificates, at the moment in Italy the obligations provided for in Article 10 of Legislative Decree 332/2000 shall continue to apply, untill twenty-four months after the date of the publication of the notice on the functionality of Eudamed.