Episode Details

This episode details the September 9, 2026 update to the EU's MDCG 2020-16 guidance, Revision 5. We explain the crucial clarifications on classifying in-vitro diagnostic (IVD) quality control (QC) materials under the IVDR. The discussion focuses on the distinction between QC materials with manufacturer-assigned values versus those with only indicative values, and how this directly impacts a product's risk class and its required conformity assessment pathway, including the need for notified body involvement. Key Questions: - What is MDCG 2020-16 Revision 5 and why is it important for IVD manufacturers? - How does the updated guidance change the classification of quality control (QC) materials? - What is the key difference between QC materials with "assigned values" versus "indicative values"? - How does this classification impact the required conformity assessment route under the IVDR? - If a QC material is for a Class D assay, what is its new classification? - Why are non-assigned value QC materials typically considered Class A? - What immediate steps should regulatory teams take to comply with this guidance? - Does this change require notified body involvement for products previously self-certified? - How should manufacturers update their technical documentation and labeling? Sources: - https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en How Pure Global can help: Pure Global provides end-to-end regulatory consulting for IVD and MedTech companies navigating complex regulations like the EU IVDR. Our experts develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative to streamline market access. By combining local expertise with advanced AI, we help you correctly classify your devices, engage with notified bodies, and ensure your documentation meets the latest standards like MDCG 2020-16. To accelerate your global market access, visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free regulatory AI tools and database at https://pureglobal.ai.