RFID on a Medical Disposable Kit - Active Medical Device?

N

nikolaos

#11
Thank you all for your comments. The RFID tag is passive with no battery. If i understand well from your comments, it should not be an active medical device and i agree. For your information i knew now that our certification body classifed it as an "Active Medical Device"
 
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M

Martin IT

#12
They gave you a justification for their decision? It would be interesting to understand the reasons for their choice.
 
N

nikolaos

#14
Our CB:
Our medical disposable kit with a passive (no battery) RFID tag attached directly on the kit becames an active medical device because it uses the external RF energy transmitted by the reader to transit RF energy even if this lasts for few ms.
In my opinion this is an extreme interpretetion of the active medical device definition.
 
M

Martin IT

#15
Thanks for the information!

I reckon it is a very extremely interpretation, if I am able to find more info I will share with the cove ;) .
 
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