Unique device identification (UDI)
A UDI is a globally recognized numeric or alphanumeric code mandated by regulatory bodies to identify specific medical devices throughout their entire lifecycle, ensuring traceability and patient safety.
Description
The UDI system is a regulatory requirement in major markets including the US, Europe and China. The code consists of two parts: the Device Identifier (UDI-DI), which identifies the specific model, and the Production Identifier (UDI-PI), which tracks lot numbers and expiration dates.
While the UDI is a label on the physical product, it presents a significant content challenge. This unique code must be accurately reflected across all associated documentation, including Instructions for Use (IFU), technical files and safety reports. Inconsistencies between the physical label and the documentation can lead to non-compliance and market delays.
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
Regulatory Compliance
It ensures adherence to strict medical device regulations (such as EU MDR and FDA requirements), preventing costly recalls or fines.
Data Integrity
By treating the UDI as a single source of truth within a structured content system, organizations eliminate the risk of mismatched codes across different documents.
Traceability
It facilitates the rapid identification of devices in the event of adverse events or field safety corrective actions, directly enhancing patient safety.
RWS perspective
RWS understands that in the MedTech industry, content accuracy is a matter of patient safety. Our structured content solutions (Tridion Docs) allow Regulatory Affairs teams to define a UDI once and reuse it across thousands of documents and languages. This ensures that every Instructions for Use (IFU) and technical file references the correct identifier automatically, reducing the risk of human error and streamlining the path to global market access.