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/WG UDI/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.