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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 discuss the concept of data sufficiency. Specifically, we 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.
Key Takeaways
- Learn what is deemed sufficient clinical data for certain device groups
- Determine how to establish a legacy device as a ‘standard of care’ device
- Understand the conformity assessment pathways for well-established technology devices
Who Should Watch?
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.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD & Scientific Writing Services
Stacie Beecham, Principal Medical Writer
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