Keyword Analysis & Research: italian medical device database


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Frequently Asked Questions

Can hospitals in Italy supply medical devices without registration?

In fact, according to the Ministry of Health Decree (DM) issued on December 21, 2009, without this mandatory registration medical and surgical devices cannot be supplied to Italian hospitals.

What is the database of medical devices?

The database of medical devices collects information related to all medical devices released in the Italian territory by domestic manufacturers. However, the registration of medical devices by European or non-European manufacturers who wish to distribute their medical devices in Italy is limited to those belonging to classes higher than I.

How will Italy's CND codes be used in the Eudamed device database?

The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature. CND codes will be mapped to Global Medical Device Nomenclature (GMDN) for ease of use. Using CND nomenclature provides public access to medical device codes within Eudamed.

Why is RDM registration required in Italy?

The registration in the Database and Repertory of Medical Devices (RDM) is mandatory in order to supply medical devices and equipment to hospitals in Italy. In fact, according to the Ministry of Health Decree (DM) issued on December 21, 2009, without this mandatory registration medical and surgical devices cannot be supplied to Italian hospitals.


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