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Strengths of the US and EU medical device systems. US High level of patient safety FDA competence globally acknowledged Public Trust Flexible risk-based system that acknowledges the variety of device types High level of scientific and medical expertise Robust post-market authority. EU
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Strengths of the US and EU medical device systems US • High level of patient safety • FDA competence globally acknowledged • Public Trust • Flexible risk-based system that acknowledges the variety of device types • High level of scientific and medical expertise • Robust post-market authority EU • High level of patient safety • Cost efficient system to the taxpayer • Balance of responsibilities between: • Authorities • Conformity Assessment Bodies (Notified bodies) • Manufacturers • Appropriate conformity assessment costs and timings • Frequent checking across all middle and high risk classes • Both foreign and EU manufacturers treated and checked in the same way
