Ask the Expert: Understanding Clinical Data Sufficiency and Strategies to Address Limited Clinical and Performance Data

During this Q&A session, our medical regulatory experts discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also explain how to adjust the Clinical Evaluation Plan to align with the regulatory strategy, as well as answer questions about legacy devices, WET devices, and devices exempt from clinical investigations under Article 61.

Who is this webinar for? 

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of clinical evaluation reports for MDR submissions.

September 7, 2022 Watch at a Convenient Time Recorded

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To watch the free webinar recording, Ask the Expert: Understanding Clinical Data Sufficiency and Strategies to Address Limited Clinical and Performance Data, fill out the form below.


Takeaways from this session:

  • Understand the differences between a well-established technology and a legacy device
  • Learn the impacts of data and the route to conformity
  • Discuss the meaning of data sufficiency in the CER
  • And more!
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