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FDA vs. EU: Decoding Medical Device Risk and Classification Pathways
This episode demystifies the critical process of medical device classification in the US and EU. Learn the principles behind risk-based classification and how it directly impacts your path to market, from documentation to regulatory scrutiny.
Key Questions:
• What are the three medical device risk classes in the United States?
• How does the EU's four-class system (I, IIa, IIb, III) differ from the FDA's?
• Why is a device's classification the single most important factor for its regulatory strategy?
• What is a 510(k) and when is it required?
• What is a Premarket Approval (PMA) application?
• How does risk level determine the need for a Notified Body in Europe?
• What is a CE Mark and how is it related to device class?
• What are the consequences of misclassifying your medical device?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.
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By Pure GlobalThis episode demystifies the critical process of medical device classification in the US and EU. Learn the principles behind risk-based classification and how it directly impacts your path to market, from documentation to regulatory scrutiny.
Key Questions:
• What are the three medical device risk classes in the United States?
• How does the EU's four-class system (I, IIa, IIb, III) differ from the FDA's?
• Why is a device's classification the single most important factor for its regulatory strategy?
• What is a 510(k) and when is it required?
• What is a Premarket Approval (PMA) application?
• How does risk level determine the need for a Notified Body in Europe?
• What is a CE Mark and how is it related to device class?
• What are the consequences of misclassifying your medical device?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.