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.
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 2026 and published in the Official Journal of the European Union (#OJEU) today 30 January 2026:
▶️ Commission Implementing Decision (EU) 2026/193 of 28 January 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, non-active surgical implants, sterilization of health care products, biocompatibility evaluation of breathing gas pathways in healthcare applications and small-bore connectors for liquids and gases in healthcare applications (OJ L, 2026/193, 30.1.2026, ELI: https://lnkd.in/eqg9FH8e).
This adds 12 new references for the MDR, reaching 48 overall.
▶️ Commission Implementing Decision (EU) 2026/197 of 28 January 2026 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of health care products and information supplied by the manufacturer (labelling) (OJ L, 2026/197, 30.1.2026, ELI: https://lnkd.in/evmV7FX9).
This adds 6 new references for the IVDR, reaching 23 overall.
Many thanks to CEN and CENELEC and their experts in the Technical Committees, and to the #HAS consultants! 👏👏
👉 All the updated information on #Standardisation for medical devices is available on the European Commission EU Health and Food Safety DG #SANTE webpage on “Public Health > Medical Devices – Topics of Interest > Harmonised standards” https://lnkd.in/eNRyh6re.
