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