EUDAMED 360° – UDI Standards, Strategies & Best Practices
Giada Necci
Alessia Frabetti
Valerio Gigante
Key Takeaways from the Webinar
Join our webinars to explore the latest regulatory compliance strategies in the medical device industry. Our experts provide practical solutions and answer your questions live.
Understanding UDI Structure Is Crucial
The implementation of UDI in Europe involves several layers: Basic UDI-DI, Master UDI-DI, UDI-DI, and UDI-PI. Each code serves a different function and must be managed accordingly for compliance with MDR and IVDR.
Choosing the Right Issuing Entity Matters
Manufacturers must choose an accredited Issuing Entity like GS1 to generate and manage their UDI codes. This ensures global recognition and compliance across regulatory systems such as EUDAMED and GUDID.
Notified Bodies Play a Dual Role
Notified Bodies like KIWA are involved both before and after device registration, supporting validation of documentation and ensuring regulatory accuracy throughout the lifecycle.
Master UDI-DI is a New European Requirement
This new identifier acts as an intermediate step between the Basic UDI-DI and UDI-DI, and is currently required for specific product categories (e.g., contact lenses), with more expected to follow.
Data Synchronization Is Key to Long-Term Compliance
ACKOMAS provides seamless integration with EUDAMED, allowing automated data synchronization, secure publication, and traceability, making regulatory operations more efficient.
EUDAMED Should Be Part of a Sustainable Regulatory Strategy
Integrating EUDAMED into your quality and data management system is not just a legal obligation—it’s a strategic move that ensures market access, audit-readiness, and long-term operational continuity.
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