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Understanding UDI Series
Gain 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.
Slides and PDF
Video Tutorials
Related Resources
EUDAMED Compliance: A Practical Guide for 2025
With the UDI/Device Registration module in the EU’s EUDAMED database expected to begin mandatory product reporting in January 2026, the window to prepare is rapidly closing.
Breaking Down the EU’s Latest EUDAMED Functional Confirmation
On 2025-Nov-27, the European Commission published a EUDAMED Functional Notice in the Official Journal of the European Union (OJEU) announcing that several major EUDAMED modules
EUDAMED UDI Compliance
With the final phase of EUDAMED UDI implementation looming, the myth of “more time” is putting manufacturers at risk. The recent 3-month delay is not a grace period — it’s a wake-up call. If you haven’t already submitted to EUDAMED, you’re not just behind schedule — you’re in jeopardy of noncompliance.
EUDAMED Rollout Delay
The European Commission (EC) has missed a key milestone in the rollout of EUDAMED, the central database for medical devices in the EU. According to the previously published timeline, EUDAMED was expected to be declared “fully functional” by July 1, 2025
Understanding UDI
Unique Device Identification (UDI) requirements vary by country and regulatory authority. Select a health authority below to access jurisdiction-specific guidance and resources.
USA
EUROPEAN UNION
CHINA
SOUTH KOREA
AUSTRALIA
SWITZERLAND
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.
