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Strengths of the US and EU medical device systems

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

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  1. 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

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