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  • 1.  Animal testing in medical devices

    This message was posted by a user wishing to remain anonymous
    Posted 23-Nov-2022 12:43
    This message was posted by a user wishing to remain anonymous

    Hi everyone, 

    I'm looking for some opinion about the need for animal testing. 
    Is there any need to do biocompatible testing in animals in transvaginal probes which obviously are in contact with the intravaginal mucosa, but not directly because they may have a sheath covering them?
    Furthermore, I would also like to ask opinion about performing in vivo animal tissue studies to demonstrate this type of device's clinical safety. 

    Thank you in advance and best regards,



  • 2.  RE: Animal testing in medical devices

    Posted 25-Nov-2022 09:08
    Hi Anon

    Clearly for the sheath there will be a need for biocompatibility evaluation. For the probe, maybe. What is the risk that the sheath could be breached and leave the probe in contact with the patient?

    Decisions about in vivo animal tissue studies will be a matter of judgment - first the manufacturer's and then the regulator(s)' opinions. Ethically, it is important to avoid unnecessary animal studies, and there may be general agreement that such studies are unnecessary in the case of materials that have already been thoroughly studied.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Animal testing in medical devices

    Posted 01-Dec-2022 16:04

    Hi Annon 

    To your question. Is there any need to do biocompatible testing in animals in transvaginal probes which obviously are in contact with the intravaginal mucosa, but not directly because they may have a sheath covering them?

    You will need to assess the contact type and duration of every material and component of your transvaginal probe and perform a risk assessment of possible contact and duration as per ISO 10993-1. This will help you identify the type of biocompatibility testing you might need to cover. Please remember that some authorities may have additional biocompatibility requirements. E.g.  EU MDR -> assessments of raw materials against CMR 1A or 1B and/or ED phthalates and materials of natural or animal origin, Canada -> BPA, and so on. 

    Opinion, I would advise taking a look at ISO-10993-2, which would help you analyze if any scientifically valid means can be used to not require animal tests.

    Hope this helps 

    Andrea 

    Hope this helps!



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    Andrea Sanchez
    QA/RA Specialist
    Montreal QC
    Canada
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    Original Message


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