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  • 1.  SCHEER Benefit Risk Assessment - Support needed

    This message was posted by a user wishing to remain anonymous
    Posted 27-May-2021 08:34
    This message was posted by a user wishing to remain anonymous

    Dear Experts,

    Our devices contain a component (not patient contacting directly/indirectly) that contain and CMR/ED SVHC above 0.1% w/w.

    We identified an alternative and have been planning implementation in two months time. However this week the new component has just failed accelerated aging. This leaves us in an impossible situation where we will need to follow the SCHEER guidance and perform a benefit risk assessment in order to obtain a CE mark under MDR as we don't have time to address and re-age the component.

    We need a consultancy to support in the BRA from a toxicological, material science (polymer) and clinical perspective. 

    Advice and recommendations needed please!


  • 2.  RE: SCHEER Benefit Risk Assessment - Support needed

    Posted 27-May-2021 09:00

     

     

    Hi Anon,

     

    As part of our regulatory and biocompatibility consulting services, we work with a number of different consulting toxicologists.  Happy to make recommendations if you would like to contact me directly.

     

    Best regards,

     

    Ted

     

     

     




    Original Message


  • 3.  RE: SCHEER Benefit Risk Assessment - Support needed

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2021 09:03
    This message was posted by a user wishing to remain anonymous

    Hi Anon, 

    If your component is not patient contacting directly/indirectly, I assume there is another criteria under GSPR 10.4.1 that applies to your device, such that you need to ensure compliance with the 0.1% w/w limitation on CMR & ED substances?  My interpretation is that this GSPR does not have a blanket application to all devices. 

    Devices, or those parts thereof or those materials used therein that:
    - are invasive and come into direct contact with the human body,
    - (re)administer medicines, body liquids or other substances, including
    gases, to/from the body, or
    - transport or store such medicines, body fluids or substances,
    including gases, to be (re)administered to the body,

    shall only contain the following substances in a concentration that is
    above 0,1 % weight by weight (w/w)
    Original Message


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