New Italian Classification of Medical Devices (CID): What Changes from 2026

Di Nicolò Rossi - Legal Manager

 

As of 1 January 2026, the Italian Classification of Medical Devices (CID) has entered into force following a decree issued by the Italian Ministry of Health and approved by the State–Regions Conference. The CID fully replaces the former National Classification of Medical Devices (CND), in use since 2007, marking an important step in the alignment of the Italian regulatory framework with EU standards.

The new classification stems from the need to ensure consistency with the regulatory architecture introduced by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), overcoming the limitations of a purely national nomenclature in an increasingly harmonised European market.

One of the key changes introduced by the CID concerns its structure: the first seven hierarchical levels fully mirror the European nomenclature, significantly facilitating data interoperability and the registration of devices within the European database Eudamed. This structural convergence reduces administrative friction and enhances regulatory coherence across jurisdictions.

The CID has also been designed to reflect ongoing technological innovation, introducing more granular codifications for fast-evolving areas such as medical software, as well as for devices incorporating advanced safety features, which are now clearly distinguished from standard versions.

From an operational perspective, the transition from the CND to the CID will require both companies and healthcare providers to review their internal processes. Manufacturers and importers will need to adapt registration activities, assess the consistency of technical documentation and ensure adequate internal training, while healthcare facilities will need to update procurement and device management systems.

The CID will be subject to regular updates, confirming its role as a dynamic regulatory tool. Far from being a mere coding exercise, the new classification represents a concrete step towards deeper integration between national implementation measures and EU medical device law.