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MDR, RED and LVD - Should our device comply with them?

#1
Hi,
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 or any other LVD harmonized standard? 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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#2
Hi.. I am very interested in the answer to this. Did you get any information. I would also like to know if the move to the 62368-1 is mndated for products falling under the EMC Directive
 
#3
Hi,
I've informally spoken with an auditor from the notified body and according to him, any medical device has to comply with 62368-1 (most common) or other LVD harmonized standard.
 
#4
Hi,
I have a MD class Im product that has a Wifi and then needs to comply with RED. the product is already compliant to EMC/LVD and the compliant as well to EN 300 328.
Can I then conclude that my MD is compliant to RED ?
 
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