Everything you need to know about UDI

UDI identification and traceability in the EU-MDR

The medical device industry is constantly evolving, with new regulations being introduced to enhance patient safety, improve product traceability, and increase market transparency. One of the most significant developments in this area is the Unique Device Identification (UDI) system. But what exactly is UDI, why is it important, and how will the upcoming regulatory changes impact manufacturers?

What is a UDI and why is it important?

A UDI is a unique code assigned to medical devices, ensuring they can be easily identified and tracked throughout the supply chain. The code consists of two key components:

Device Identifier (DI): A fixed code that identifies the specific model of a device.
Production Identifier (PI): A variable code that includes details such as batch number, serial number, and expiration date.

Why does this matter?

Faster recalls: Defective or unsafe products can be quickly identified and removed from the market.
Better traceability: It is possible to track medical devices from the manufacturer to the end user.
Greater transparency: Healthcare authorities and regulators can easily verify whether a device meets the required standards.

New UDI regulations coming in 2025

From 2025, the EUDAMED registration system will become fully operational. This means that manufacturers will not only be required to generate a UDI but must also register it in EUDAMED.

Additionally, new guidelines have been introduced for:

UDI marking on software: Software classified as a medical device must now include a UDI.
Reusable medical devices: Additional requirements apply to devices that are reprocessed and reused.

To remain compliant, manufacturers must start preparing now and ensure that their processes align with these regulatory changes.

Which organizations issue UDI codes?

The European Commission has designated four official organizations responsible for issuing UDI codes:

GS1 AISBL – A globally recognized organization that develops product identification standards.
HIBCC – Specializes in identification standards for the healthcare sector. To obtain a UDI through HIBCC, manufacturers must first apply for a Label Identification Code (LIC), which comes with fees based on company revenue.
ICCBBA – Manages the ISBT 128 standard, primarily used for blood products and transplants.
IFA GmbH – A Germany-based organization specializing in pharmaceutical identification, offering the Pharmacy Product Number (PPN) as a UDI-compliant identifier.

Manufacturers must carefully choose the issuing agency that best suits their product type and business needs.

What should manufacturers do now?

With these changes on the horizon, it’s essential to plan ahead. Key steps manufacturers should take include:

Selecting the appropriate UDI issuing agency and ensuring their products meet the required standards
Verifying compliance with new regulations, especially for software-based and reusable medical devices
Registering their UDI codes in EUDAMED before the mandatory deadline
Keeping up with regulatory updates to avoid any compliance issues

Conclusion

The implementation of the UDI system marks a significant step forward in the medical device industry. It enhances safety, ensures traceability, and creates a more transparent market.

For manufacturers, staying compliant means acting now. By working with an authorized UDI issuing agency, following regulatory guidelines, and ensuring EUDAMED registration is properly handled, businesses can remain competitive and ready for the future.

Want to learn more about how your company can prepare for these changes? Stay informed and don’t take any chances!

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