Centralized National System

Healthcare organisations rely on a wide range of medical devices whose availability, performance, maintenance, and safety directly affect the quality of care. This project develops a unified, end-to-end system to support the inventory, lifecycle management, and safety vigilance of medical device equipment across healthcare services, to improve traceability, performance monitoring, and timely risk response. Through this project, Greece establishes a single, nationwide framework that unifies medical device equipment management and vigilance across the public hospital network, thus setting a new European benchmark for traceability, performance oversight, and patient safety response.

The project’s core aims are to:

• Establish a Central System for Management and Surveillance covering the full range of medical device equipment across all public hospitals.

• Ensure nationwide coverage across 129 public hospitals.

• Simplify end-to-end processes, from procurement and commissioning to decommissioning—while also supporting the monitoring of adverse incidents.

• Create a National Registry to enable efficient tracking of cost, quality, and safety, and to support evidence-based planning and investment decisions.

• Develop a National Vigilance Database—a central repository for adverse incident reports and recall information sourced from EUDAMED.

The project is demonstrating excellent implementation progress, with strong endorsement from all involved stakeholders. INBIT’s professional performance has been widely recognised, with the initiative described as a “model project.” Key targets and milestones have been achieved well ahead of the scheduled timeline.