Regulatory Open Forum

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  • 1.  Disposal regulation for a small medical device battery powered

    Posted 23-Mar-2022 11:56
    Edited by Mauro Rinaldi 23-Mar-2022 12:31
    Dear RAPS experts,
    Does anyone have recommendations regarding applicable regulations about battery  and product disposal requirements for a small medical device battery powered to be marketed in both Europe and in the US? 
    As per my knowledge, in the EU the battery undergoes the regulation 2020/0353 (repealing directive 2006/66), the product, as it contains electronic, undergoes WEE directive 2012/19/EU and 2005/32/EC which establishes a framework for the setting of echo-design requirements for energy-using products. Any help to complete the regulatory framework in the EU and know more for the US?

    Thank you!


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    Mauro
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  • 2.  RE: Disposal regulation for a small medical device battery powered

    Posted 26-Mar-2022 19:29
    Dear Mauro,

    There are a variety of regulations and standards that may be applicable depending on the battery technology and device type... rechargeable or single-use, implantable, lithium or lead-acid or nickel-cadmium or whatever, and different relevant testing requirements if you're having a battery made to your specifications or choosing one off-the-shelf. Some important US rules include 

    Public Law 104-142  https://www.epa.gov/rcra/mercury-containing-and-rechargeable-battery-management-act-public-law-104-142

    Lithium Battery Transportation  https://www.phmsa.dot.gov/lithiumbatteries  or  https://www.iata.org/en/programs/cargo/dgr/lithium-batteries/


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    Anne LeBlanc
    United States
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