Category Guidance Document Organisation International Medical Device Regulators Forum (IMDRF) ID IMDRF/UDI WG/N7FINAL:2013 Type Standard Access Open Status Active Created Dec-13 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 Access UDI Guidance: Unique Device Identification (UDI) of Medical Devices By accessing this content, you are leaving this website. The Agency takes no responsibility for the accuracy of content on the destination page.