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  • 1.  MDR - Class I reusable

    This message was posted by a user wishing to remain anonymous
    Posted 19-Dec-2019 12:58
    This message was posted by a user wishing to remain anonymous

    Is that limited to reusable surgical instruments ?  or the scope is broader ? 

    If our device specify that certain parts of the device should be cleaned  ( cleaning instruction is provided with commercially available cleaning solution -  not sterilization of any kind) between patients use, is that consider a reusable  device ? 
    Many thanks in advance.


  • 2.  RE: MDR - Class I reusable

    Posted 19-Dec-2019 19:19

    It seems as if your post left out something at the beginning. Perhaps I can answer your question by explaining the process.

    The first step is to classify the device using the rules in Annex VIII. With the class in hand, determine the available conformity assessment paths in Article 52. Pick one and follow it.

    If your device is Class I, then apply Article 52(7). It has a general case on three special cases, one of which is a reusable surgical instrument. Annex VIII(2.3) provides the definition.

    The MDR does not have a definition reuse or reusable but the concept is in the Article 2(39) definition of reprocessing. Annex I(23.4)(n) covers reusable devices regardless of class.

    In the colloquial sense, your device, sounds to me, as a reusable device that require reprocessing between uses.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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