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EU IVDR Clarity: Navigating IVD Performance Studies with MDCG 2025-5
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…
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