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EU MDR & IVDR Simplification: What the 2025 Proposal Means for MedTech
This episode unpacks the European Commission's significant proposal of December 16, 2025, aimed at the targeted simplification of the MDR and IVDR. We explore the potential impacts on documentation, digitalization through EUDAMED, and what these changes could mean for manufacturers, especially SMEs, as they navigate the complex European regulatory landscape. Key Questions: - What specific changes are included in the EU Commission's "targeted simplification" proposal? - How could the proposed MDR/IVDR updates affect documentation and compliance costs? - What role will digitalization and the…
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