The new regulations establish a Unique Device Identification (UDI) system for medical devices, except custom-made devices and devices for performance studies or investigations. It follows internationally recognised principles and uses definitions compatible with those of major trading partners.
The UDI system will make devices easier to trace, improve the effectiveness of post-market safety activities and enable better monitoring by competent authorities. It will also help reduce medical errors and combat falsified devices, while improving purchasing, waste disposal and stock management.
A set of frequently asked questions explains the system and how it will be applied.