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  • 1.  Latest Harmonized Standards for the MDR and IVDR

    Posted 30 days ago

    The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions.

    For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological evaluation, radiation sterilization dose, sterile device packaging (finally), and processing of healthcare products.  Specifically, these are:

    • EN 455-3:2023,
    • EN ISO 10993-15:2023,
    • EN ISO 10993-17:2023,
    • EN ISO 10993-18:2020 including EN ISO 10993-18:2020/A1:2023,
    • EN ISO 11137-2:2015 including EN ISO 11137-2:2015/A1:2023,
    • EN ISO 11607-1:2020 (FINALLY!) including EN ISO 11607-1:2020/A1:2023,
    • EN ISO 11607-2:2020 including EN ISO 11607-2:2020/A1:2023, and
    • EN ISO 17664-2:2023.

    View the corresponding implementing decision for the MDR here.

    For the IVDR, these are harmonized standard entries No. 11 through 13 and they relate to radiation sterilization dose and sterile device packaging. Specifically, these are:

    • EN ISO 11137-2:2015 including EN ISO 11137-2:2015/A1:2023,
    • EN ISO 11607-1:2020 (FINALLY!) including EN ISO 11607-1:2020/A1:2023, and
    • EN ISO 11607-2:2020 including EN ISO 11607-2:2020/A1:2023.

    View the corresponding implementing decision for the IVDR here.

     



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 2.  RE: Latest Harmonized Standards for the MDR and IVDR

    Posted 29 days ago

    Thanks for the update!

    For convenience: An overview over the initial implementing decisions for harmonised standards and all amendments is availabe for MDR here and for IVDR here. On the linked pages there are additional links to (unofficial) summary lists with all currently harmonised standards for the respective regulation.



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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    Original Message


  • 3.  RE: Latest Harmonized Standards for the MDR and IVDR

    Posted 26 days ago

    Thanks for the update Kevin !



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


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