Understanding Medical Device Classification and Regulatory Pathways

Objectives

• Identify the US FDA pathways to market as well as their advantages and disadvantages.
• Apply a strategy to choose an appropriate regulatory pathway.
• Describe how to establish substantial equivalence for a 510(k) premarket notification.
• Identify the necessary sections of a 510(k) premarket notification.
• Explain the role of the CE Mark in the EU.
• Describe EU device classifications and pathways to market.
• Identify the necessary sections of a Technical File.
• Identify the impact of the new EU device regulations (MDR and IVDR) and preparation challenges.
• Describe regulatory submission best practices.

Who Should Attend

Medical device quality and regulatory affairs professionals with a need to understand how to select an appropriate regulatory submission/clearance pathway for a medical device in the US and/or the EU.