The expert panel specializing in the circulatory system has evaluated a notified body clinical assessment of a completely new class III implantable device used in cardiology, a tricuspid valve replacement system and called for more studies.
Expert Panel Opinion Defers EU Market Entry For Tricuspid Valve Replacement System
Once again, an EU expert panel has challenged the adequacy of a notified body review of the manufacturer’s clinical evaluation report, clearly tightening up on high-risk device oversight.
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