EU MDCG 2020-16 Rev 5: IVDR Classification for IVD Quality Control Materials

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-09-26

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? ...