Webinar

Bridging the Gaps: Determining When Clinical Data is Necessary to Demonstrate Conformity with GSPRs

What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists, and the device meets specific criteria. In this webinar, we will discuss the concept of data sufficiency. Specifically, we will explain the differences between a well-established technology and a legacy device as defined by MDR and discuss strategies from both a regulatory and writer's perspective. 

Who is this forum 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.  

August 3rd, 2022 Watch at a Convenient Time Recorded

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To watch the free webinar recording, Bridging the Gaps: Determining When Clinical Data is Necessary to Demonstrate Conformity with GSPRs, fill out the form below.

 

Takeaways from this session:

  • Understand what is deemed sufficient clinical data as determined by the MDR
  • Learn how to establish a legacy device as a ‘standard of care’ device
  • Hear what considered sufficient clinical evidence and ‘high quality data’ for Class III legacy devices
  • And more!
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