Population
10 cardio-vascular interventions with 27 newly CE approved medical devices evaluated in Austrian…
Comparison
European market authorization evidence… vs USA market authorization evidence requirements
Design
Systematic_review
Authors
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FDA-mandated large RCTs strengthen risk-benefit assessment before approval; challenges Europe's earlier, less rigorous CE-mark pathway.
Market authorization based on mature clinical data from larger RCTs, as required by the FDA, changes the perspective on the risk-benefit ratio and secures patient safety compared to the earlier, less rigorous European CE marking process.
Wild et al. (2014) studied this question.
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