Optimizing Your Performance Evaluation Report (PER) for IVDR
The European Union’s In Vitro Diagnostic Regulation (IVDR) presents a rigorous regulatory framework that demands high standards of clinical evidence, making the Performance Evaluation Report (PER) a critical document for […]
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 […]
[FEATURED] European Regulatory Roundup, July 2022: Threat of Ongoing Hurdles Masks Progress
The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for the MDR and IVDR implementation. But with major hurdles ahead, in July […]
