Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.

Orphanet J Rare Dis · 2023 · PMC10369713 · PMID 37491269

Europe PMC DOI

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a positive trendno p-value reported

However, despite a positive trend towards more RCTs for medical devices [ 10 ], this is still not the standard approach to the clinical development of medical devices in Europe.

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