EU – Update of the lists of harmonised standards for MDR and IVDR

The EU published two implementing decisions expanding the list of harmonised standards for MDR and IVDR. The decisions add 8 standards for MDR (25 in total) and 3 for IVDR (13 in total). The newly added standards address aspects of biological evaluation, processing (both for MDR), radiation sterilization and sterile packaging (MDR and IVDR). Consolidated summary lists of harmonised standards can be found on the respective EU websites for MDR and IVDR.