The EUDAMED Clock is Ticking: Understanding the EU's Mandatory 2026 Deadlines

from Medical Device Global Market Access

This episode details the crucial update on the EUDAMED gradual roll-out. We explain the impact of the European Commission's Implementing Decision (EU) 2025/2371, which confirms the functionality of the first four EUDAMED modules. The discussion covers which modules are now live, the official start date for mandatory use—May 28, 2026—and what actions medical device and IVD manufacturers must take to ensure compliance for market access in the European Union. Key Questions: - What is Commission Implementing Decision (EU) 2025/2371 and why is it important? - Which four EUDAMED modules are now officially considered functional? - What is the exact date that mandatory use of these EUDAMED modules begins? - How does the gradual roll-out affect registrations for new and legacy medical devices? - What are the immediate actions manufacturers must take to prepare for the 2026 deadline? - Will the Vigilance and Clinical Investigation modules also be mandatory in 2026? - What is a Single Registration Number (SRN) and why is it essential? Struggling with complex regulatory changes like the EUDAMED rollout? Pure Global offers end-to-end consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using advanced AI to compile technical dossiers. Our services cover the entire product lifecycle, from initial market research to post-market surveillance. Let us help you navigate the EU market with confidence. Visit us at https://pureglobal.com/, contact [email protected], or explore our free AI tools and database at https://pureglobal.ai.

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This episode is 3 minutes long.

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This episode was published on January 25, 2026.

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