UDI Guidance: Unique Device Identification (UDI) of Medical Devices

This document provides non-binding rules to support the regulation of medical devices. It replaces the guidance document: Guidance on a Unique Device Identification (UDI) System for Medical Devices.

This guidance provides a framework for regulatory authorities that intend to develop their UDI Systems. The framework can be used at a local, national, or global level such that these systems are implemented without regional or national differences. This guidance is intended to provide a high-level conceptual view of how a global UDI System should work, and supports a globally harmonised approach to the UDI.

Main sections:

· Rationale, purpose and scope

· References

· Definitions

· Guidance for a UDI System

· The UDI

· UDI Carrier

· The UDI Database (UDID)

· Rules for specific device types