Regulation of Medical Devices in the United States and European Union

Key Points

• The aim is to compare the regulatory frameworks for medical devices in the United States and the European Union.
• Analyzed regulatory requirements for high-risk medical devices in the US and EU.
• Examined the impact of these regulations on clinical testing and patient access.
• The US requires more rigorous clinical testing for high-risk devices than the EU.
• This rigorous testing delays patient access to new devices but may enhance overall device safety.

Abstract