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

MateuszN

Registered
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.
 

MikeKilkelly

Starting to get Involved
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
 

MateuszN

Registered
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.
 

Dana Kelly

Registered
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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