Regulatory Open Forum

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  • 1.  RoHS II: repaired/returned IVDs

    Posted 25-Jul-2016 11:59

    Hello all,

    The case involves an individual IVD, which is a piece of EEE, but does not comply with RoHS II because it was placed on the market before 22 July 2016. If it is returned to the manufacturer for repair and then sent back to the customer sometime after 22 July 2016, would it have to be RoHS II compliant upon return?

    Any thoughts on this would be very greatly appreciated. 

    Best,

    Justin

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    Justin Osmond
    Nepean ON
    Canada
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  • 2.  RE: RoHS II: repaired/returned IVDs

    Posted 26-Jul-2016 10:45

    I had this situation arise in a prior job, and at the time we asked for advice from our NB, among others. The answer we got is that because service parts are exempt, and the device itself is exempt, this device would not have to be "brought up" to RoHS2 simply because of the service, as long as it is returned to the same customer.

    However, if the device was a "refurb" and sold to a different customer, then it would need to meet the updated RoHS requirements.

    Of course, there is always the possibility that the customs office that receives it isn't aware of this, so there could be some delays depending on the country.

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States