This episode demystifies the requirements for In-Vitro Diagnostic (IVD) performance studies under the EU's IVDR. We explore the crucial guidance document, MDCG 2025-5, published in June 2024, to clarify common points of confusion for manufacturers. We cover the key differences between study notifications and applications, what constitutes a 'substantial modification,' the rules for using leftover samples, and how to manage combined studies, helping you avoid costly delays and regulatory rework.

Key Questions:

- What is the difference between a performance study notification and an application under IVDR?

- When do I need to re-submit if I make changes to my study protocol?

- Can we use leftover patient samples for our IVD performance study?

- What does MDCG 2025-5 say about substantial modifications?

- How does the EU regulate studies combining an IVD and a medicinal product?

- Why is correctly classifying my IVD study crucial for avoiding delays?

- What are the documentation requirements for studies using archived samples?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. Our experts, backed by advanced AI tools, streamline global market access. We develop efficient regulatory strategies for performance studies and pre-submission activities to minimize rejections. Our team handles the compilation and submission of technical dossiers, ensuring compliance with complex regulations like the EU IVDR. Whether you're a startup or a multinational, Pure Global provides the local expertise and technology-driven solutions to get your product to market faster. Contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.