In UDI, each medical device has a distinctive identification code which facilitates improved product safety and overall supply chain management.
The UDI system aims to enhance patient safety by providing accurate and accessible information about medical devices, ensuring quick identification, monitoring and response to any issues related to their use.
This standardised identification system is globally harmonised, streamlining communication and co-ordination within the healthcare ecosystem.
What are the benefits of UDI?
- Increased patient safety
- Improved post-market surveillance
- Enhanced capture of correct information
- Enhanced business processes
GS1 standards for UDI
GS1 is an issuing agency for UDI, which means that GS1 standards can be used to comply with specific regulatory UDI requirements.
GS1 is recognised as one of the standard development organisations accredited by the regulators for UDI issuance. Other organisations include HIBCC and ICCBBA.
How it works
Medical device manufacturers become members of GS1.
GS1 members are allocated a unique GS1 Company Prefix.
Medical device manufacturers assign globally unique GTINs to their medical devices. These GTINs are the Device Identifiers (DI) which UDI regulations commonly refer to.
These GTINs are captured in GS1 barcodes with production information such as expiry date/LOT, therefore enabling the capture of accurate information through a simple scan.
Who is responsible for assigning the UDI-DI?
Depending on the regulation, it is typically the manufacturer or "labeler" that is responsible for complying with all UDI requirements.
This includes:
- The assignment of the UDI (and Basic UDI-DI)
- Registration of the UDI in the appropriate database (e.g., Eudamed, GUDID)
- The placement of the UDI data carrier on the device (if reusable) and/or label/packaging
You can learn more about GS1 standards and UDI on the GS1 Global Office website.