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  • 1.  e-IFU (EU) 2021/2226

    This message was posted by a user wishing to remain anonymous
    Posted 24-Aug-2022 08:44
    This message was posted by a user wishing to remain anonymous


    one of the requirement for electronic IFU in regulation (EU) 2021/2226 article 5:
    (4) they shall provide, on the device or a leaflet, information on foreseeable medical emergency situations 

    how do you interpter this requiremet? what information should be included in the leaflet? 
    and what does it mean "on the system"? label? 

    thank you!

  • 2.  RE: e-IFU (EU) 2021/2226

    Posted 25-Aug-2022 03:19

    This is really dependent on the device type and how this requirement is applied.  A leaflet, Quick Guide, instructions pamphlet, etc., should contain sufficient information regarding safety (and performance) of the device without having to refer to the full instructions.  This could be warnings on the quick guide, caution stickers, or other means.  On the system itself or on the device this would be labels, stickers, cautions, warnings, for things like electricity, heat, etc.  It is not necessarily the same, definitely a different risk level, but when you buy a new printer it has the leaflet and then when putting in the toner/cartridge there is individuals stickers or labels to do something or not do something.  Again this highly depends on the device to include specific information on/with the device that would be needed.

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

  • 3.  RE: e-IFU (EU) 2021/2226

    Posted 25-Aug-2022 08:11
    Hello Anon

    As a first step define the medical emergency situations, and how they can be caused. Then determine if your device is actually involved in addressing these emergency situations. Only if your device is involved, you need to follow (EU) 2021/2226 article 5 (4).

    A system in this context means in our interpretation a defined process that is based on functional and regulatory requirements, risk assessed and validated against these requirements,



    Hans Strobel