Regulatory Open Forum

 View Only

  • 1.  RoHS II and CE marking for medical devices

    Posted 28-Mar-2013 14:26
    Good morning all! I would like to start a general discussion about strategies for RoHS II compliance for devices in light of CE marking.

    It appears that one way to address compliance is to go through the Bill Of Materials for a given product and ensure that all the components within the product are RoHS II compliant. This can be a substantial undertaking depending on the complexity of the device in question.

    Are there other viable approaches? How are you approaching RoHS compliance for your devices?

    Cheers,

    Joanne Pelaschier
    Engineering Services Specialist III
    Stellartech Research Corporation
    Sunnyvale, CA



  • 2.  RE:RoHS II and CE marking for medical devices

    Posted 29-Mar-2013 08:29
    I guess authorities will review Bill of Material,  assembly drawing and other relevant documentation and you could just have the final product could just undergo XRF testing to ensure that it is roHS compliant

    -------------------------------------------
    Rajeev Aneja
    Johnson & Johnson
    Princeton NJ
    United States
    -------------------------------------------






    Original Message


  • 3.  RE:RoHS II and CE marking for medical devices

    Posted 29-Mar-2013 10:29
    I would recommend RoHS II FAQ guidance be reviewed to address compliance issues.   


    Original Message


  • 4.  RE:RoHS II and CE marking for medical devices

    Posted 29-Mar-2013 10:32
    I would recommend RoHS II FAQ guidance be reviewed to address compliance issues.  



    Original Message


  • 5.  RE:RoHS II and CE marking for medical devices

    Posted 01-Apr-2013 16:50
    Unfortunately, going through the Bill Of Materials for a given product and ensuring that all the components within the product are RoHS II compliant is the only sure way to do it. This can be a substantial undertaking for some products.  You need to go through the supply chain to get answers regarding RoHS and make sure their answers seem credible.

    I am not familiar with XRF testing - do you need visible line of sight to all components?   That could be difficult.

    Willard Sickles, PE
    Manager, Product Safety & Compliance Engineering
    Intermetro Industries
    Wilkes Barre PA
    United States
    -------------------------------------------






    Original Message


  • 6.  RE:RoHS II and CE marking for medical devices

    Posted 02-Apr-2013 01:59
    Joanne,
    the answers sugested so far are correct from my point of view. I saw a presentation on a system that was developed on behalf of many companies that were in need of a easy solution on REACH and ROHS compliance about two years ago.
    Check out BOMcheck. I think it is the easiest approach to handle this.

    -------------------------------------------
    Florian Tolkmitt
    sfm medical devices GmbH
    Germany
    florian.tolkmitt@sfm.de
    -------------------------------------------






    Original Message