Software as a Medical Device (SaMD) Technical File Requirements

#1
Our company makes medical stimulation devices which contain software integral part. We are now developing a device which can be controlled by the user’s mobile phone instead of the usual remoted control. In future the user will be able to download stimulation treatment software programs targeting specific medical conditions from the AppStore. My understanding is that this will classify it as “stand alone software” and Software as a Medical Device (SaMD). My question is how to CE mark the software? Should it be CE marked in the same Technical File as the device it’s intended to be used with or should it have its own Technical File?
 
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yodon

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#2
Per the IMDRF's definition of SaMD:

Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.

So, are you sure it's SaMD? On the surface, it would seem more of an accessory. If you develop under 62304, you'll at least have the necessary materials, either way.
 
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