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Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities.
This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them:
Understanding the shift from MDD to MDR (Article 61 & Annex XIV)
Why weak Clinical Evaluation Plans (CEPs) lead to rejection
How to generate and analyze real, device-specific clinical data
Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system
Maintaining a “living” Clinical…
The skinny
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