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Interview: EU Or US? Deciding On The Best Market Entry Point Amid Evolving Clinical Requirements

Executive Summary

The timescale for CE-marking devices that require clinical studies may stretch to at least double the timescale for US 510(k) clearance as the EU landscape evolves, according to consultant Maria Donawa. In a Q&A with Medtech Insight, she assesses the ongoing changes and whether the clinical data requirement scales are tipping to such an extent that the US will increasingly be a favored point-of-market entry.

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