EU IVDR: Navigating New Deadlines and Stricter Rules

Medical Device Global Market Access

The European Union's In Vitro Diagnostic Regulation (IVDR) has replaced the IVDD, introducing a stricter, risk-based classification system and increasing Notified Body oversight for most devices. This episode breaks down the fundamental changes, the expanded scope that now includes software and genetic tests, and the critical extended transition deadlines established in July 2024, providing manufacturers with a clear roadmap for compliance. • What is the EU IVDR and how does it differ from the previous IVDD? • What are the new risk classifications (A, B, C, D) for IVDs? • How has the role of Notified Bodies changed under the new regulation? • What are the latest extended transition deadlines for high, moderate, and low-risk IVDs? • Are all IVD devices eligible for these extended deadlines? • What are the specific conditions for a legacy device to qualify for the transition period? • How does the IVDR affect medical device software and companion diagnostics? • What happens if a manufacturer’s IVDD certificate expired before the new extension? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.