Unique device identification (UDI)

The UDI is a global unique device identifier. It is assigned to medical devices in the UDI system in the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. 

It is a unique numeric or alfa-numeric code placed on the label of medical devices. It contains two components: the device identifier (UDI-DI) and the production identifier (UDI-PI). It is important to mention that the UDI is used alongside labelling requirements – it does not substitute them.

How does structured content authoring help? 

The UDI provides users with precise information on the medical device throughout its lifecycle. It also alerts users to any adverse events or field safety corrective actions that are required. The product label provides a wealth of information and must remain clearly readable and unaltered in any way throughout the documentation. 

With a structured content authoring tool, the UDI identification number can be defined as a source of truth and easily reused and inserted in any documentation section without ambiguity.

Key benefits

  • Allow easy UDI usage throughout the documentation with content reuse 
  • Eliminate the risk of using by mistake different or incorrect UDI numbers across the dossier 
  • Quickly identify all the instances in the dossier where the UDI number has been used for easy verification of correctness or replacement in case of error