The MDR CE certification applies to the TricValve system as a Class III active implantable medical device for patients with symptomatic severe tricuspid regurgitation (TR) and caval reflux who are at high risk for open-heart surgery. Patient eligibility is not limited by native tricuspid annulus size or right heart anatomy, and the presence of pacemaker leads is not a contraindication.

MDR certification reinforces TricValve’s regulatory foundation following its original CE mark under the former Medical Device Directive (MDD) in 2021. The MDR replaces the MDD and significantly raises regulatory, clinical, and post-market surveillance requirements. Class III devices previously certified under the MDD must achieve MDR compliance by May 2027 to remain commercially available in the European Union.