Insights

The Italian Ministry of Health has introduced an updated classification system for medical devices, known as the Classificazione Italiana dei Dispositivi Medici (CID). This new framework, effective January 2026, will enhance the management, tracking, and regulation of medical devices in Italy, ensuring greater compliance with EU regulations.

Key features of the CID:

• Hierarchical Coding System: The CID will categorize devices into a detailed alphanumeric structure. The first seven levels will align with the European Medical Device Nomenclature (EMDN), while subsequent levels address specific device characteristics.
• EU Alignment: The CID is fully aligned with the EU Regulation 2017/745, providing a robust framework for device registration, monitoring, and safety reporting.
• Streamlined Updates: The classification will be regularly updated to reflect changes in the medical device landscape, ensuring ongoing relevance and precision.
• Collaboration with Stakeholders: The system's development includes contributions from regulatory bodies, regional authorities, and the medical device industry.

This measure will promote transparency, improve safety monitoring, and optimize the procurement and clinical management of medical devices.

RPN will provide timely updates on the evolving medical device regulatory landscape and is ready to offer expert and flexible support for all regulatory needs.