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.
When it comes to EU declarations of conformity, BUDI-DI is a critical main key for EUDAMED device registration and UDI database records.
See a short excerpt below.
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.
Check out the full video! It has some great examples of the BUDI-DI structure. Thank you for populating this form to view the full episode of Reed Tech Insights – European Union Basic UDI-DI
For the latest published guidance from the European Commission concerning BUDI-DI, see: