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  • 1.  Wearable product color change

    Posted 24-Nov-2020 12:33
    Hi,
    For a wearable device with CE Mark (EU MDR & ISO 13485:2016), if the company is planning to change the colors & size of the product, what are the testing the company will need to re-do (esp. will the biocompatibility testing needs to be redone)? Please suggest.

    Thanks in advance,
    Ritam

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    Ritam Priya
    VP Quality & Regulatory
    Fremont CA
    United States
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  • 2.  RE: Wearable product color change

    Posted 25-Nov-2020 06:13
    Dear Ritam, it depends.
    it depends on the impact of the changes in color and size on the verification and validation results. The risk management activities should help you analyzing the impact of these changes into your control measures and the associated verification and validation activities. A justification of the use of the current biocompatibility results is possible, but I am not a biocomp expert.

    Be aware that changes in color and size can also have impact on usability aspects depending on the intended use and user profile; these design changes may lead to additional usability validation activities.
    Use your risk analysis as a pivot to address the product changes and find the associated changes in control measures and the associated verification and validation activities.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
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    Original Message


  • 3.  RE: Wearable product color change

    This message was posted by a user wishing to remain anonymous
    Posted 25-Nov-2020 12:14
    This message was posted by a user wishing to remain anonymous

    Hi Ritam,

    Like most regulatory questions, it depends. Your notified body will most likely require you to perform a biocompatibility testing to prove that new color die won't pose new risks (irritation, cytoxicity, etc.). It may be possible to leverage the previously done biocompatibility testing along with existing information on color die (perhaps vendor has done testing) to establish a connection to justify that no new testing is needed.

    As for size change, I think Peter answered it perfectly. Your risk management activity should guide your answer as to if new usability testing is needed.

    Original Message


  • 4.  RE: Wearable product color change

    Posted 23-Feb-2021 22:27
    Thanks for your responses. I have a follow up question on strap size. If the strap is a component of a wearable device, will it be possible to sell it as a component/replacement part? What is the definition of component versus accessory according to EU MDR? How are the requirements different?

    ---------------------------------
    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
    ---------------------------------



    Original Message


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