Impact of IVDR on Clinical Diagnostics Practices

This case study explores the implications of the European Union's In Vitro Diagnostics Regulation (IVDR) on clinical laboratories, focusing on Ganzimmun Diagnostics. It highlights the challenges faced by labs in transitioning to IVDR compliance, including the need for revalidation of in-house assays and the importance of collaboration with manufacturers like Tecan. The study emphasizes the regulatory changes affecting the entire supply chain and the critical role of post-market vigilance in ensu