We are delighted to share that Inion Hexalon™ Bioabsorbable Interference Screw has been CE certified according to the new EU Medical Device Regulation by our Notified Body British Standards Institute (BSI). The MDR assessment includes high scrutiny of the device’s clinical safety and performance, to ensure that the product represents current state-of-the-art in both technical and clinical aspects.
In addition, Inion’s Quality Management System has been certified according to the EU MDR. The regulation brings many changes such as new requirements for post-market surveillance phase and data entry to EUDAMED database.