LexisNexis EU EUDAMED UDI Requirements & Compliance Resources
LEXISNEXIS LIFE SCIENCES SOLUTIONSUnderstanding UDI SeriesGain answers to your questions about Unique Device Identification (UDI). Book time with a UDI expert for in-depth Q&A plus access to a library of tutorials and reference materials
EU EUDAMED UDI
The European Commission has implemented the European Database on Medical Devices (EUDAMED) to support centralized device registration and regulatory oversight across the European Union. The system requires economic operators — including manufacturers, authorized representatives, and system or procedure pack producers — to submit and maintain regulatory and UDI information across six structured modules.
Implementation has progressed in phases, with activity underway in the Actor Module and the Device/UDI Registration Module. As EUDAMED continues to evolve, manufacturers must address module-specific data requirements and understand key differences from the US FDA system, including concepts such as Basic UDI-DI (BUDI-DI).
As part of the Understanding UDI Series, this page provides access to slides, PDFs, video tutorials, and related resources to support organizations managing EUDAMED UDI compliance.
LexisNexis Life Sciences simplifies that complexity. We support manufacturers across the entire product lifecycle — from initial market entry and UDI data preparation to ongoing updates, change management, and post-market compliance. Our global regulatory expertise and technology-driven solutions help ensure your device data stays accurate, synchronized, and inspection-ready, so you can focus on innovation while we help safeguard compliance.
Video Tutorials
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Need Guidance on UDI Compliance?
Understanding UDI obligations across global health authorities can be complex. Whether you are preparing for initial submission, managing product data updates, or aligning compliance across multiple markets, our regulatory experts provide practical guidance tailored to your organization’s needs.