Using in vitro data in CE marking submission of Medical Devices

Our CEO Carla Landolfi was a speaker during the webinar “Using in vitro data in your CE marking submission of Medical Devices” organized by SenzaGen company.

This webinar focused on strategies to eliminate animal testing and expedite time-to-market by using in vitro testing outcomes for assessing cytotoxicity, skin irritation, and skin sensitization in biological evaluations.

It is important to notice that this approach aligns with the EU Medical Device Regulation 2017/745 (MDR) and supports the CE-marking process for medical devices, offering a more efficient and humane path to regulatory compliance.

In recent years, there has been a significant shift towards the adoption of in vitro testing methods as a preferred alternative to traditional in vivo approaches. This transition is not only driven by scientific advancements but is also guided by the principles of the ‘3Rs’ – Replacement, Reduction, and Refinement – which emphasize the reduction of animal testing, minimizing animal suffering, and improving the overall efficiency and ethics of research. In vitro methods have proven to be highly effective, providing reliable data while aligning with modern scientific and ethical standards.



Open chat
Don't hesitate to contact us for any inquiry!