Strengths of the US and EU medical device systems

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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