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.

Enlarged eye of tax inspector looking through magnifying glass, inspecting offshore company financial papers, documents and reports.

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.

The product has no CE marking. Indeed this is the first tricuspid replacement system where a company has applied for...