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Apple Watch is not a medical device. How can this be possible?

François

Involved In Discussions
#1
Hello all,

After the FDA clearance, it seems that Apple has obtained the CE certification for its ECG App. However, I'm surprised that the Apple Watch is not considered as a medical device by Apple or their Notified Body.

I wonder how this has been justified since the Apple watch should be considered as an accessory according to the MDR or the MDD and have the same classification as the software.

What could have been their strategy to avoid having the hardware certified by their Notified body? I'm really interested by your takes on this. Like I said in a previous thread, I'm not an expert in regulatory affairs so I can't figure how they've managed this.

For info: I've attached their IFU (Not really nice symbol resolution or cropping by the way).
 

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Ronen E

Problem Solver
Staff member
Moderator
#2
Their strategy? Being Apple.
It ties up nicely with the FDA creating their special program for "select" SW Manufacturers.
 
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