Artivion is advancing toward EU Medical Device Regulation (MDR) certification across a significant portion of our portfolio.
Our Commitment
At Artivion, quality is at the heart of everything we do. We develop simple, elegant solutions to help cardiac and vascular surgeons address the most complex challenges in aortic disease. Our focus is clear: deliver innovative technologies of unsurpassed quality that improve patient outcomes.
Why MDR Certification Matters
In Europe Medical Device Regulation (MDR) represents an evolution for medical device safety, clinical evidence, and performance.
Why We’re Ready
Artivion’s portfolio is built on decades of innovation, robust quality systems, and close collaboration with surgeons worldwide. This foundation positions us to meet the elevated requirements of MDR with confidence. A growing number of our products have achieved MDR certification.
MDR-Certified Products
Engineered for performance.
Artivion’s MDR-certified portfolio supports surgeons across a range of aortic and cardiac procedures. MDR versions of the following products are already commercially available.
BioGlue®
Surgical Adhesive
Chord-X®
Mitral Chordal
Replacement Products
PhotoFix®
Decellularized Bovine
Pericardium
MDR versions of the following products are not yet commercially available.
On-X®
Aortic Heart Valve
On-X®
Mitral Heart Valve
On-X®
Ascending Aortic Prosthesis
E-nside™ TAAA
Multibranch Stent
Graft System
E-tegra™
Stent Graft System
E-liac™
Stent Graft System
Beyond our currently certified portfolio, several additional products are in the pipeline and moving toward MDR approval.
What This Means
MDR certification delivers value where it matters most—to patients.
- Proven, certified devices
- MDR requirements backed by rigorous standards.
- A trusted partner committed to supporting surgeons and advancing patient care
Even after the end of 2027, we will be able to maintain product supply, ensuring full continuity throughout the MDR transition.
for E-nside™, E-tegra™, E-liac™, BioGlue®, and PhotoFix®
for Chord-X®, On-X®
MWENG0077.000 (2026-07)