Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD […]
IVD Post-Market Surveillance: Best Practices Under IVDR
In the rapidly evolving landscape of in vitro diagnostic (IVD) regulations, the implementation of the In Vitro Diagnostic Regulation (IVDR) marks a significant shift. This new regulation demands more rigorous […]
IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to […]
