Navigating UDI compliance in the EU: Practical approaches for complex and special device categories
£50.00
Learn actionable strategies for managing UDI for complex and special device classifications while maintaining regulatory efficiency
English
The European Union’s (EU’s) Unique Device Identification (UDI) system serves as a foundational mechanism for enhancing device traceability, post-market surveillance, and patient safety. While the UDI framework is well-defined for standard devices, its implementation presents substantial technical and regulatory challenges for complex and special device categories. The purpose of this article by Caterina Grandi, Giulia Pastore and Silvia Tamarri is to equip regulatory professionals with essential insights for crafting effective regulatory strategies. It draws on first-hand experience in navigating exceptions and streamlining UDI processes for complex device categories, and highlights the importance of a tailored, strategic approach. Customising UDI implementation to the specific needs of each device category is essential for achieving full compliance and sustaining long-term market success.
Specification: 15 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2025 issue of the Journal of Medical Device Regulation.
