UDI Guidance: Unique Device Identification (UDI) of Medical Devices 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 offers a framework for regulatory authorities that intend to develop their unique device identification (UDI) systems.
Unique Device Identification system (UDI system) Application Guide Category Guideline Organisation International Medical Device Regulators Forum (IMDRF) ID IMDRF/UDI WG/N48FINAL:2019 Type Standard Access Open Status Active Created Mar-19 This application guide provides the details and specifications necessary for a harmonised approach to applying the requirements of the IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013).