Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project
Alan G. Fraser, Sergio Buccheri, Robert A. Byrne, Per Kjærsgaard‐Andersen et autres
Before a high-risk medical device is approved for implantation into patients, there should be evidence not only of its performance and safety with a favourable benefit-risk ratio, but also of its clinical efficacy. Regulatory guidance on study methodologies is lacking, however, so …
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11 citations
The Lancet Regional Health - Europe