Standalone software - an accessory to medical device?

[Kh_Nadja]

Dear All!

Could you please help me to define if our standalone software is an accessory to our medical device or not.

I use the definition of accessory given in MDD:
"article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device".

1. The standalone software is not a medical device itself (it only uploads the data from the device to a computer);
2. This software is specifically intended to be used together with the device (not for use with any other devices);
3. The device achieves its intended purpose even without the software involved (software provides just an additional way for data visualization, which may be skipped altogether).

So, what would you say? Is it an accessory?

Thanks in advance for your suggestions!

 

[GenDir]

In my opinion this software is not an accessory - it is only an option for the device: The device fulfills it intended use without this software - so the software is not necessary for the medical use of the device.


But keep in mind: it depends for what the uploaded data are used. Are these for medical purposes? So it could be that the software would be considered as a medical device

 

[yodon]

When you say (the software provides an) "additional way for data visualization" - do the users base any decisions based on this additional way of visualization? If so, then probably an accessory. If they just say "ooh, that's pretty" and then go back to the other system for making decisions, then maybe not.

I think I'm probably saying the same as GenDir, just maybe in a slightly different manner.

 

[malasekhar]

Hi In your case, the software is an accessory to the device. Since it supports the device in transferring the data and visualization without any influence on the device.

Conditions to consider software as a Medical device (Active Medical Device):
1. Should have any intended medical purpose - Classification rules apply
2. Should drive the device or influence the device (in this case software falls under the device's class itself)

Note: If software supports or supplement to the intended use of a medical device it is an accessory only.

 

[dgrainger]

It doesn't sound like it is an accessory as the device "achieves its intended purpose even without the software involved".
The "additional way for data visualization" may make it a device in its own right though!