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  • 1.  Conflict minerals

    Posted 13-Jul-2022 11:44
    I am aware of SEC reporting requirements on use of conflict minerals (tantalum, tin, tungsten and/or gold), but are there medical device regulatory requirements in the US or elsewhere regarding use of these materials?

    Many thanks!

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    Julia Anastas
    San Carlos CA
    United States
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  • 2.  RE: Conflict minerals

    Posted 14-Jul-2022 06:00
    Hello Julia,

    As far as I know, there is no specific medical device regulatory requirements for conflict materials; use of these materials is more at a federal level in the United States.  However, from my time in industry I remember there were reporting requirements for importing materials (from suppliers) and exporting finished devices which contained certain materials for certain countries.  I just remember it was not easy to find all of the information in one location, and did have more to do with import/export.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Conflict minerals

    Posted 14-Jul-2022 10:34

    From the EU commission link below.  We contract Mfg for other EU medical companies they require this from us. 

    A new EU law to stem the trade in conflict minerals

    Therefore, the EU passed a new regulation in May 2017 to stop:

    • conflict minerals and metals from being exported to the EU;
    • global and EU smelters and refiners from using conflict minerals, and;
    • mine workers from being abused.

    The law also supports the development of local communities.

    It requires EU companies to ensure they import these minerals and metals from responsible sources only.  

    The requirements start to apply on 1 January 2021.



    https://policy.trade.ec.europa.eu/development-and-sustainability/conflict-minerals-regulation_en#:~:text=A%20new%20EU%20law%20to,mine%20workers%20from%20being%20abused.

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    Barry Welenc
    Director, Quality & Regulatory
    La Grange IL
    United States
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    Original Message


  • 4.  RE: Conflict minerals

    Posted 15-Jul-2022 11:57
    Thank you Richard and Barry for your replies.  Appreciate the help.

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    Julia Anastas
    San Carlos CA
    United States
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    Original Message


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