Authoring Group: IMDRF UDI WG
Date: 12 July 2018
The IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013) provides a framework for the regulatory authorities that intend to develop their UDI systems in a globally harmonized approach. This UDI system Application Guide is to be used as a supplement to the IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013) which was developed as a high-level conceptual framework containing the basic core concepts of a UDI system. The document further acknowledges that additional guidance may be necessary.
This UDI system Application Guide, together with the IMDRF UDI Guidance (IMDRF/WGUDI/N7Final:2013), provide a harmonized approach to UDI system implementation. Each is primarily intended for medical device regulatory authorities and manufacturers that plan to develop and implement UDI systems.
However, the benefit and purpose of a UDI system will only be realized, if healthcare stakeholders integrate and obtain value in their systems from UDIs and data in associated Unique Device Identification Databases (UDIDs). This guide is therefore also intended to assist all relevant stakeholders within the healthcare supply chain and clinical care systems to gain a better understanding of their role and impact on the UDI system