Traceability of medical devices – everything you need to know about the UDI system

In a sector as sensitive as medical devices, patient safety, information transparency, and product traceability are top priorities. It is with these goals in mind that the Unique Device Identification (UDI) system was introduced. Implemented by the FDA in the United States and adopted by the European Union under the MDR and IVDR regulations, the UDI aims to improve the traceability of medical devices throughout their entire lifecycle.

In this article, we explore the regulatory foundations, objectives, structure, implementation, and challenges of the UDI system.

Origins and Objectives of the UDI

The concept of UDI (Unique Device Identification) emerged in the United States in the 2010s as an initiative by the Food and Drug Administration (FDA) in response to several incidents involving poorly tracked device recalls. The idea of a standardized, unique identifier for each device has since spread globally.

Key objectives:

• Improve traceability of medical devices throughout the supply chain.
• Enhance patient safety by facilitating the reporting of incidents and product recalls.
• Support post-market surveillance (vigilance).
• Promote transparency and information access for healthcare professionals and patients.
• Combat counterfeiting in the medical device market.

A Bit of History

The idea of a unique identifier for medical devices began taking shape in the early 2000s, driven by the growing need for improved traceability of healthcare products. The FDA took the lead in 2007 following several high-profile health scandals and recalls of misidentified devices. The UDI system was formally introduced into U.S. regulation under 21 CFR Part 830 in 2013, with the goal of making every device traceable from production to use. All medical devices were required to carry a unique identifier generated through an accredited system (such as GS1, HIBCC, or ICCBBA) and be registered in the Global Unique Device Identification Database (GUDID).

The European Union followed suit through the MDR and IVDR regulations, introducing its own mandatory UDI requirements. Implementation has been phased in, starting in 2021 for class III and implantable devices, and extending through May 26, 2025, when it becomes mandatory for class I devices.

This regulatory alignment is part of a global movement to modernize medical device oversight systems, led in part by the International Medical Device Regulators Forum (IMDRF).

Structure of the UDI

The UDI system is based on a standardized structure that allows each medical device to be uniquely identified while ensuring the traceability of its production batches. It is composed of two main elements: UDI-DI and UDI-PI.

UDI-DI (Device Identifier)

The UDI-DI is the fixed portion of the identifier. It identifies the specific model of the device and is unique to each manufacturer. The UDI-DI serves as a key for registration in regulatory databases such as EUDAMED (EU) or GUDID (USA). It only changes if significant changes are made to the product (such as changes in intended use, performance, or design).

UDI-PI (Production Identifier)

The UDI-PI is the variable portion of the identifier. It provides production-specific information and may include:

• Lot or serial number
• Manufacturing date
• Expiration date
• Unique unit identifier
• Software version, if applicable

These elements are essential for detailed traceability, especially in the event of recalls or incident reports.

Example of a UDI

A complete UDI might look like this: (01)03453120000011(17)260101(10)B1234

• (01): UDI-DI (device identifier)
• (17): Expiration date (formatted YYMMDD)
• (10): Lot number

This data is typically encoded in a linear barcode or DataMatrix format, and also printed in human-readable text on the device label or packaging.

UDI codes must be assigned by accredited issuing agencies such as GS1, HIBCC, or ICCBBA, following internationally recognized standards.

Conclusion

The introduction of the UDI system marks a major step forward in the global regulation of medical devices. By ensuring each product is uniquely, legibly, and consistently identified, UDI not only facilitates traceability and recall management but also enhances transparency for users and health authorities. For manufacturers, implementing UDI presents organizational challenges—but also an opportunity to modernize quality systems and logistics processes. Now adopted across both the EU and the U.S., the UDI is becoming a global standard that no medical device stakeholder can afford to ignore.