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  • 1.  EN ISO 14971:2019 A11:2021

    Posted 15-Jan-2022 11:05
    BSI has now published the UK version of 
    BS EN ISO 14971:2019 A11:2021 which is now available at BSI Standards
    This will be the Harmonized version of EN ISO 14971:2019 when the next list is published in the OJEU. While not Harmonized until the publication in the OJEU, it can still be used as a "state of the art" medical device risk management standard. It contains Annex ZA for medical devices and Annex ZB for In Vitro Medical Devices for aid in demonstrating compliance to the GSPR in the MDR and IVDR regulations.

    Other European Standards suppliers should be releasing their versions of this important horizontal standard which applies to all medical devices and IVDs soon.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
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  • 2.  RE: EN ISO 14971:2019 A11:2021

    Posted 17-Jan-2022 02:30
    Thanks for the info, Ed! From the German DIN, the consolidated DIN EN ISO 14971/A11 is scheduled to be released in March.

    All the best,

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    Patrik Brehm
    Senior Manager Quality Strategy
    Veeva MedTech
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    Original Message


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