Clinical Data Requirements Under MDR: A Panel Discussion
NAMSA invites you to join us for an interactive panel discussion on clinical data requirements and challenges under MDR, led by our in-house regulatory experts. Even with the extended MDR transition period for legacy devices, it’s crucial to have a strong clinical data plan for all devices. We’ll begin by addressing common clinical data challenges manufacturers face under MDR, drawing from our experience with clients and notified bodies. Then, we’ll dive into an interactive panel discussion.
Attendees will gain insights into:
- Clinical Evaluation Report (CER) requirements
- Defining adequate clinical evidence
- Evaluating clinical benefits
- Strategies for Post-Market Follow-Up (PMCF)
- Expectations of Notified Bodies regarding clinical data
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