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Unique Device Identification (UDI) Application Guide

The purpose of this Work Item is to promote a globally harmonized approach to the application of a UDI system, supporting the principles laid down in the general IMDRF UDI Guidance Document (IMDRF/WG/N7Final:2013). The Work Item is, therefore, intended to contribute to the achievement of the perceived benefits of UDI for regulators and stakeholders implementing UDI around the globe

The working group will develop an IMDRF Technical Document that will provide an Application Guide for UDI providing guidance (definition, instruction, context, etc.) needed for a globally harmonized approach to the application of a UDI system.

  • Harmonized Unique Device Identification (UDI) Application Guide

Working Group Chair: Salvatore Scalzo, European Union

Working Group Membership: Regulator and stakeholder membership (membership to be advised)