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  • 1.  Implant card - Dental implant - Germany

    Posted 22-Jun-2021 02:28
    Dear all,

    I am asking just out of curiosity, because I got a dental implant ("artificial root") this month (June 2021) myself. I did not get an implant card, which rather surprised me.

    I presume that the certification of the implant is still according to MDD, but in Germany, the physician or clinic had to present an implant card even prior MDR because of the German regulation MPBetreibV (Medizinprodukte-Betreiberverordnung) §15.
    The MDR excludes some implant types in article 18 (3), like dental crowns and fillings. Does that mean that I won't get an implant card for an artificial root as well?

    Maybe some expert could enlighten me, before I ask my dentist for something I won't need ;-)

    Thank you!

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    Britta Cyron
    Quality Manager
    Dorsten
    Germany
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  • 2.  RE: Implant card - Dental implant - Germany

    Posted 12-Jul-2021 12:25
    Hello Britta

    A dental implant (in the sense of an artificial root) manufacturer will have to provide proof of a 'patient implant card system' for MDR certification. A quality dental implant manufacturer will provide you/your dentist a dental impart card also under MDD certification. 

    The bove is the regulatory view (very much abbreviated). The patient (your) view is that you should have specific and detailed information about the implant you got implanted because if you should need prosthetic work on the implant in the future this information is very important.

    Hope this helps.

    Best regards,

    Hans

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    Hans Strobel
    www.dokspot.io
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    Original Message


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