We are excited to share that the Inion CPS™ and Inion CPS™ Baby Bioabsorbable Fixation Systems have been CE certified according to the new EU Medical Device Regulation by our Notified Body British Standards Institute (BSI) as of February 1st, 2023. The certification verifies that the products meet all regulatory requirements for medical devices under the new Medical Devices Regulation (MDR) and allows us to market and sell our products in the EEA (European Economic Area). The MDR assessment includes high scrutiny of the device’s clinical safety and performance, to ensure that the product represents the current state-of-the-art in both technical and clinical aspects.
Inion CPS™ and Inion CPS™ Baby are our bioabsorbable solutions for cranio-maxillofacial surgery. The target population of Inion CPS™ products under the CE mark is adult patients, and the Inion CPS™ Baby is intended to treat pediatric patients. The fixation systems contain resorbable plates, meshes and screws in different shapes and sizes. You can find out more on the Inion CPS™ and Inion CPS™ Baby product page.