Device with WiFi communication - EU MDR vs. EU RED

RA_QA_Expert

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Hello,
we are developing a medical device which will send some data wireless via 5 GHz WiFi to another mobile devices and/or hospital systems.

Besides EU MDR we plan to apply Radio Equipment Directive (RED). But the scope of the RED is radio equipment operating with ‘radio waves’ of frequencies lower than 3 000 GHz. That means 5GHz WiFi module is out of the scope. What should we apply? Any advice will be very appreciated.

Thank you
 
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