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The Future of Regulatory Submissions: AI Integration and Digital Transformation
July 22, 2025
4 mins
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Regnova Blogs
Navigated EU MDR’s Enhanced Requirements: A 2025 Compliance Guide
July 22, 2025
3 mins
The European Union’s Medical Device Regulation (EU MDR) has reshaped the regulatory landscape for medical device manufacturers across the continent - and beyond. In 2025, the full force of EU MDR compliance is no longer about preparation, but active execution. From stricter clinical data requirements to real-time post-market monitoring, manufacturers must align both strategically and operationally to maintain market access.
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