Unique Device Identification system (UDI system) Application Guide

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). The IMDRF UDI Guidance provides a framework for the regulatory authorities that intend to develop their UDI systems in a globally harmonised approach.

Main sections:

· Scope

· References

· Definitions

· Fundamental elements of a harmonised UDI system

· Guiding principles for UDI system design and operations

· The Unique Device Identifier (UDI)

· Application of UDI to packaging levels

· The Unique Device Identification Database (UDID)

· Recording Unique Device Identifiers into forms, databases (other than UDID), registries and other health information

· Establishing Responsibility for Creating and Maintaining a UDI System

· General Considerations to facilitate an effective UDI Implementation

· Special cases

· Emerging issues with UDI which are not specifically covered by this Guide

· Appendix A: UDI HRI formats to be used for each of the issuing agencies/entities

· Appendix B: AIDC carriers most widely used in healthcare

· Appendix C: Examples of RFID carriers

· Appendix D: Examples of registration of packaging configurations

· Appendix E: Examples of UoU and packaging configurations

· Appendix F: Feasibility issues linked to direct marking integrity

· Appendix G: Kit Examples

· Appendix H: Examples of changes to configurable medical devices

· Appendix I: Example of UDI assignment for software