Regulatory Open Forum

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  • 1.  QMSR

    Posted 22-Feb-2023 19:43

    I learned today that the current Unified Agenda says publication of the final rule is scheduled for Dec. 2023.

    The formal title is Medical Device; Quality System Regulation.

    As an aside, when the rule is published some device manufacturers will need to implement three versions of 13485. Some regulators, such as Canada, will expect ISO 13485:2016. The EU will expect EN ISO 13485:2016/A11:2021. The US will expect QMSR, a modified version of ISO 13485:2016.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 2.  RE: QMSR

    Posted 23-Feb-2023 11:03
    Edited by Mark Swanson 23-Feb-2023 19:10

    Hi Dan,

    I had seen this notification some time ago as well. I wonder if you see any significant differences between the quality system expectations for the geographies you outline or if there is a difference over what is currently being done?

    EU--implementation is actually for the Medical Device Regulation and In vitro Diagnostic Regulation (EU MDR/IVDR), using Annex IX (full quality system) path of conformity. It is simply that EN ISO 13485:2016/A11:2021 meets most of the quality system requirements and the Z Annexes outline where requirements are either not met (fully or partially). That is, there are more requirements in the EU regulations than just ISO 13485.

    US--AAMI/ANSI/ISO 13485:2016 plus the additional regulatory requirements (labeling, reporting, etc.)

    Canada--ISO 13485:2016 plus the additional regulatory requirements in the Canadian Medical Device Regulation (reporting, registration, etc.)


    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States