Dear Members, please see below the update that ISO 17665:2024 and ISO 18113:2024 series have been added to the list of EU IVDR harmonised standards. OJ:L_202600197:EN:TXT.pdf Mario Gabrielli Cossellu • 1st 📣 Two new Commission Implementing Decisions on references of #Harmonised #Standards in support of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR) have been adopted on 28 January…
Ben KempFebruary 6, 2026