Regulatory Open Forum

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  • 1.  MDR Implant Card

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2024 14:03
    This message was posted by a user wishing to remain anonymous

    Is there any alternative option to not include physical implant cards (electronic or other options) for devices currently under Article 18 requirements?



  • 2.  RE: MDR Implant Card

    Posted 17-Jan-2024 02:52

    At the moment, no. MDR very much requires the implant card to be a physcial object in the form of a card.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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