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Discussion in 'EU Medical Device Regulations' started by mtn_sa, May 19, 2020.

  1. mtn_sa

    mtn_sa New Member

    May 19, 2020
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    I have a problem with LVD and standard 62368-1, I'm not sure if our device should comply with them. We are designing a medical device with WiFi, so: our device has to comply with MDR and RED. According to article 3.1 of RED, any radio device has to comply with safety requirements set out in 2014/35/EE but with no voltage limits. It means that our device has to comply with RED, MDR and LVD. Essential requirements form LVD are covered by standard IEC 62368-1. Does it mean that our medical device shall comply with requirements from IEC 62368-1? Are medical devices excluded from this standard because IEC 62368-1 is for "audio/video, information and communication technology equipment"?
    I wasn't able to find any information about it. I would be very grateful for your help.

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