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  • 1.  CER updates throughout lifecycle

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jul-2020 12:05
    This message was posted by a user wishing to remain anonymous

    Hi All!
    I have a question on how long you continue to update CERs after a product has hit end of life. Do you continue to update the CER through the entire obsolescence period (for example, end of shelf life or warranty) even if the tech file itself is closed? or once tech file is closed, the CER is closed as well, even if there is the potential for product to be sitting on customer shelves or capital equipment is still being used?
    thanks!
    Sara


  • 2.  RE: CER updates throughout lifecycle

    Posted 17-Jul-2020 07:49
    Hi Anon,

    The MDR specifies that depending on the class of the device, the periodic safety update report (PSUR) should be updated annually (Class IIb and III) or biennially (Class IIa) throughout the lifetime of the device.  For Class I devices, a post-market surveillance report should be updated "as necessary".  As these documents are inputs to the Clinical Evaluation Report, it follows that the CER should be updated through the life of the device, even if it is no longer manufactured/distributed.

    James

    ------------------------------
    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
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    Original Message


  • 3.  RE: CER updates throughout lifecycle

    Posted 28-Jul-2020 02:09

    James Bonds is right.
    To clarify this further: You officially need to update the CER until no product is left on the market.



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    Lukas Losigkeit
    CEO & Principal Consultant
    Hamburg
    Germany
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    Original Message


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