Impacts of European In Vitro Diagnostic Regulation (IVDR) - Professor of Molecular Medicine, UK Academic Hospital

A senior consultant in a large UK pathology network described how IVDR is impacting clinical testing in their country . T heir organization has not yet implemented changes in response to IVD R , but their relationships with manufacturers will play a significan t part in this process. The introduction of IVDR has the potential to bring positive changes by making manufacturers more responsible for understanding and clinically validating their assays. However, it could also present obstacles in day - to - day operation s if not used wisely. The stakeholder expresses concern about the regulation becoming a political weapon and underscores the need for collaboration between regulators, front - line users, and manufacturers. The stakeholder expects the cost of adopting IVDR a uthorized tests to increase, albeit indirectly, due to manufacturer's additional workload for monitoring product performance. Looking ahead, they foresee increased interaction among authorities, professional bodies, and clinical end users for successful IV DR implementation.