MDCG 2025-5 Explained: EU IVDR Rules for IVD Performance Studies

This video delivers a detailed walkthrough of the European Commission’s new MDCG 2025-5 guidance on IVD performance studies under the EU’s In Vitro Diagnostic Regulation (IVDR). Presented by Dr. Oliver Eikenberg, it clarifies how the new guidance consolidates existing IVDR requirements into a practical, Q&A-style resource designed to reduce rejections, delays, and compliance risks during CE marking.

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Topics covered in this video include:

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• The purpose and scope of MDCG 2025-5
• Study definitions and the critical role of a clearly defined intended purpose
• How to navigate study responsibilities, approvals, and modification procedures
• The decision tree for regulatory pathways under the IVDR
• Good Study Practice principles and their role in CE marking acceptance

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MDCG 2025-5 is now essential reading for all IVD manufacturers and study sponsors. It reaffirms the strict expectations around defining the intended purpose of an in vitro diagnostic device, clarifies when studies require prior notification or application to ethics committees (ECs) and national competent authorities (NCAs), and outlines the responsibilities of sponsors versus manufacturers. It also addresses how legacy data from studies conducted under the old IVDD framework may not be sufficient if it does not align with today’s clinical claims.

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Whether you’re a manufacturer or sponsor planning a new IVD study, or working to align legacy data with IVDR expectations, this video equips you with actionable insights to meet EU requirements and avoid costly delays. Read or in-depth article on MDCG 2025-5 for a deeper dive into the guidance.