Inion is pleased to announce the successful transition of its CE-marked product portfolio to certification under the European Union Medical Device Regulation (EU MDR).
All Inion products bearing the CE mark are now certified under the MDR. Reaching this important milestone reflects our continued commitment to the quality, safety and performance of our bioabsorbable medical devices and strengthens Inion’s position in the medical device market.
A significant milestone for Inion
The EU Medical Device Regulation establishes comprehensive requirements for medical devices placed on the European market, with a strong focus on patient safety, clinical evidence, product performance and post-market surveillance.
Completing the transition of our CE-marked portfolio represents an important achievement for Inion and supports our continued ability to provide bioabsorbable solutions to healthcare professionals and partners across the European market.
Updated product indications
As part of the transition to the MDR, some product indications have changed within the European Union. Healthcare professionals and partners should therefore always refer to the latest Instructions for Use (IFU) for current product information and approved indications.
Up-to-date and market-specific Instructions for Use for Inion products can be easily accessed at ifu.inion.com.
Continuing our commitment to quality
Inion has a long-standing focus on the development and manufacture of innovative bioabsorbable medical devices. Achieving MDR certification across our CE-marked portfolio is another important step in ensuring that our products continue to meet the regulatory and quality requirements of the markets we serve.
For further information about our products, their indications or the MDR transition, please feel free to contact us.