Registering medical devices in the national database

The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the procedures foreseen by the MDR until the European Database on Medical Devices - Eudamed - is fully functional. In this context, in order to meet registration obligations in Italy it is required the registration in the national database (abbreviated name DB/RDM).
 

These pages provide information on the regulations, procedures and instructions for using the national Database of Medical Devices of the Ministry of Health.