Regulatory Open Forum

 View Only
  • 1.  New EU Batteries Regulation, Article 11 - battery removibility drug delivery device

    This message was posted by a user wishing to remain anonymous
    Posted 26-Feb-2024 09:10
    This message was posted by a user wishing to remain anonymous

    Dear all, 

    This question is about the need for having the battery removable by end-user. Article 11 of Regulation (EU) 2023/1542 already giving some exemptions that are not applicable for the device in question.

    So the device is:  

    •  an electromedical device, non-invasive, used by patients themselves to administered the drug.
    • The device contains a portable, rechargeable lithium battery pack, and the lifetime of the device is shorter than the life of the battery (in this sense, the battery does not need to be replaced). 

    Considering the above, is it still mandatory to have the feature of battery's removability by the end user?

    Thank you in advance.



  • 2.  RE: New EU Batteries Regulation, Article 11 - battery removibility drug delivery device

    Posted 26-Feb-2024 12:15

    Dear Anon,

    Yes, as written, the regulation requires the battery to be removable by the end user. That should allow the device and the battery to be discarded safely in separate waste streams.



    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------



  • 3.  RE: New EU Batteries Regulation, Article 11 - battery removibility drug delivery device

    Posted 27-Feb-2024 02:39

    As far as I can see, Article 11 of Regulation (EU) 2023/1542 only mentions: '(b) professional medical imaging and radiotherapy devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745, and in vitro diagnostic medical devices, as defined in Article 2, point (2), of Regulation (EU) 2017/746.' 

    With that in mind, I would expect most medical devices need the option of having batteries removed. 

    Article 96 says that this requirement applies from 18 February 2027. It implies the industry has just under three years to get this done. Please keep in mind, this could result in a significant change.



    ------------------------------
    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
    ------------------------------



  • 4.  RE: New EU Batteries Regulation, Article 11 - battery removibility drug delivery device

    Posted 27-Feb-2024 08:53

    Hello Anon,

    As Anne describes it is about the "waste stream" how battery disposal and/or recycling can/would occur.  If the battery is not intended to be removed by the user or removable by the user - as you indicate the use life of device is shorter than the battery - then there should be clear instructions on either battery removal and disposal or disposal of the entire medical device.  As we live in a world of electronics and batteries now (autos) the need for recycling these is even greater.  While the device may be exempt under the Regulation, thinking good business etiquette and saving the environment would have instructions for proper disposal.  For me, there is not a need to have the battery removable or instructions, as long as instructions for disposal of the entire device is properly done - considering there is a battery contained in the device. 



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------