Mastering EU in-house tests: Real-World Lessons From Laboratories Under the IVDR Article 5(5)

Description: This session will provide a comprehensive overview and analysis of Article 5(5) of the IVDR, including the newly proposed amendments and their practical implications. It will include a brief overview of how in-house tests are being leveraged by pharmaceutical partners as clinical trial assays and outline what these partners can do to ensure regulatory compliance for their studies. Enforcement and implementation trends across EU Member States will be discussed, highlighting areas of convergence, divergence, and remaining uncertainty. Using a case study approach, the session will illustrate implementation strategies that help laboratories and their partners navigate regulatory requirements, structure and maintain technical documentation, and avoid common pitfalls in IVDR compliance. Particular emphasis will be placed on how laboratories and partners can navigate the regulation to best ensure patient safety through compliant in-house testing.
This session is particularly valuable for professionals working in in-house laboratory testing, IVD development, regulatory affairs, and clinical research.