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  • 1.  EU - Rechargeable Li-Ion battery classification

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2018 16:14
    This message was posted by a user wishing to remain anonymous

    Hello Everyone,

    Does anyone know what is the EU classification for Rechargeable Li-ion batteries (Secondary Battery)? Also, which MEDDEV guidance should I look at for its classification and CE requirements?

    Thank you in advance for the help.


  • 2.  RE: EU - Rechargeable Li-Ion battery classification

    Posted 01-Jun-2018 07:46
    Hello anonymous

    A battery by itself is not a medical or other device, typically it is a component of a product (consumer, industrial, electronic, medical device, etc). Batteries are governed under the Battery Directive if sold as a battery and that Directive should also be referenced as a starting point even if it is integrated into another product such as a medical device.

    Other Directives applicable indirectly are WEEE Directive and RoHS2, potentially REACH Directive.

    The typical standard(s) used to test lithium batteries are 62133 and for shipping issues, UN38.3.

    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (+1) 715-307-1850







  • 3.  RE: EU - Rechargeable Li-Ion battery classification

    Posted 03-Jun-2018 21:20
    Hi Ginger,

    Thank you for your response.

    I agree that the battery's by itself are not medical devices but, even though they are used as a component of the medical device aren't they supposed to be CE marked? What would be the classification of these rechargeable batteries?

    Thank you again.

    ------------------------------
    Pooja Dalvi
    Regulatory Affairs Specialist
    Chelmsford MA
    United States
    ------------------------------



  • 4.  RE: EU - Rechargeable Li-Ion battery classification

    Posted 04-Jun-2018 07:40
    Hello Pooja

    Sorry if I wasn't clear enough. They are CE marked under the Battery Directive. You will have to check if there are classifications there, but the type is just lithium battery- secondary cell then? 

    Other Directives may apply. 

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (715) 307-1850