EU Regulatory Affairs

EU AI Act vs FDA SaMD Compliance: 7 Critical Wins

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Let me be direct: EU AI Act vs FDA SaMD compliance is the most consequential dual-regulatory challenge facing digital health startups right now. Not eventually. Right now, in 2026, with the AI Act’s high-risk provisions fully operative. FDA’s Predetermined Change Control Plan (PCCP) guidance is simultaneously reshaping how machine-learning-enabled devices are reviewed on the US … Read more

The Critical EU MedTech Innovation Pressure: Navigating 2026 MDR & EY-DG SANTE Updates.

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The EU MedTech Innovation Pressure: Navigating 2026 “Crunch” and EY-DG SANTE Findings For years, the European Union was the global launchpad for EU MedTech Innovation, but recent data suggests a pivotal identity crisis is looming. A “CE Mark” was often the first major milestone for a startup before tackling the FDA. However, the tide has … Read more