What is UDI-DI?

UDI stands for unique device identification. The labels of medical devices contain a UDI that can be found and read by both people and machines. The UDI contains both numbers and letters in a prescribed sequence. This includes the Device Identifier, which identifies the product and company, and the Production Identifier. The unique device identification system ensures common standards for medical devices globally. Both the Food and Drug Administration (FDA) in the United States, and the European Union (EU) have established requirements for the UDI systems they have created.

These requirements were implemented to improve the safety of patients and facilitate product modernization. By requiring widespread use, both the FDA and EU have helped ensure patient safety, and have allowed for the tracking of medical devices during post-market use. The UDI helps promote medical device innovation that will benefit patients down the road.

How Does the UDI-DI System Work in the EU?

In 2019, the EU designated GS1 as the entity responsible for issuing UDI’s to medical devices. Because of the GS1 standards and regulations, global healthcare companies can create medical devices that meet those standards and will be acceptable for use by companies in the EU. Any required product information is sent to EUDAMED. EUDAMED is the IT database that stores and regulates medical devices in the European Union.

Not only does the EU have a system for UDI-DI like the FDA does in the United States, but they also recently implemented basic unique device identification or BUDI-DI. Put simply, BUDI-DI is focused on categorizing medical devices that use the same identifier in the same group. BUDI is the main identifier of a model, while the DI is the specific device unit. However, there is a lot more to BUDI-DI, especially when looking at the differences between BUDI-DI and UDI-DI, and BUDI’s use in the EU. To go a bit deeper, we talked to a UDI expert.

How is UDI different from BUDI-DI?

When it comes to EU declarations of conformity, BUDI-DI is a critical main key for EUDAMED device registration and UDI database records. 

Basic UDI-DI or BUDI-DI has a unique history in the industry, causing some confusion with the definition. In this episode of Reed Tech Insights, our resident UDI guru, Gary Saner, walks through a comprehensive history, definition and solid examples to provide a clarifying understanding of the concept. BUDI-DI is similar but different from UDI-DI. Gary will explain these differences and why they matter.

View the full episode video to gain an understanding of how and where BUDI-DI is used. Learn of the key takeaways for medical device manufacturing concerning EU conformity, documentation and reporting for EU UDI.

For the latest published guidance from the European Commission concerning BUDI-DI, see:

Medical Devices

https://ec.europa.eu/docsroom/documents/35241/attachments/1/translations/en/renditions/pdf

IVDR

https://ec.europa.eu/docsroom/documents/35242/attachments/1/translations/en/renditions/pdf