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Understanding Medical Device Classification and Regulatory Pathways

Bringing a new medical device to market in the US or EU? Need to understand how the process works in each market?

These are important considerations when choosing which market to pursue first. Using interactive discussions and workshops, we will cover the US FDA 510(k) and the EU CE Marking process in detail. You’ll walk away with a solid understanding of how the two markets overlap and differ and what will be required to gain US 510(k) clearance and/or CE Marking certification in Europe. 

Highlighted Handout

  • Matrix of EU Annex I Requirements (MDD Essential Requirements Compared to MDR General Safety and Performance Requirements)

Learn more about how Oriel STAT A MATRIX can help you during the 510(k) submission process or to attain your CE Mark.

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Course Details


  • 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.

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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