Classification Accessory Software medical device

T

TomQA

Starting to get Involved
#1
#1
Hi,

we currently have a medical device software which is a platform with therapeutic activities/games for post-stroke rehabilitation (will be class IIa with MDR).
We would like to develop a "Patient mobile app" with the following functions :
- patient is able to review his own performances
- Notifications when he need to "play" the activities/games
- Can be used as a "remote control" to play/pause games.

This mobil app therefore is an Accessory (correct?) and my question is : what is its classification ? Since it's an accessory to a class IIa device, does it need to be considered as a class IIa ?
Thank you very much !
 
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E

ECHO

Involved In Discussions
#2
#2
TomQA said:
This mobil app therefore is an Accessory (correct?)
Click to expand...
Based on what you mentioned here, I think guess that its an accessory but I feel like there isn't enough information to be sure.
For example, Is this patient mobile app used for other medical device?
Is the medical device capable of operating with out the mobile app?
Does the medical device reference the mobile app in its risk management?

TomQA said:
what is its classification ? Since it's an accessory to a class IIa device, does it need to be considered as a class IIa ?
Click to expand...
I think it should be a IIa.
 
T

TomQA

Starting to get Involved
#3
#3
Hi !
Thanks for your response.

ECHO said:
Based on what you mentioned here, I think guess that its an accessory but I feel like there isn't enough information to be sure.
For example, Is this patient mobile app used for other medical device?
Is the medical device capable of operating with out the mobile app?
Does the medical device reference the mobile app in its risk management?
Click to expand...
The mobile APP is used exclusively with our medical device and the medical device itself can be used without the mobile app.

For the moment the risks have not yet been fully identified as we're still the development phase but Yes it will be mentioned in the risk management i believe.

Do you think that this mobile app should be added inthe same technical file ?

Thanks again for your response !
 
J

Junn1992

Quite Involved in Discussions
#4
#4
TomQA said:
a medical device software which is a platform with therapeutic activities/games
Click to expand...
Based on this intended use, I would think your app is a medical device, and not accessory

I would think Class IIa => See Rule 11.

TomQA said:
Do you think that this mobile app should be added inthe same technical file ?
Click to expand...
This really comes down to intended use. At the moment, it seems like a "medical device system" to me. It is possible for one technical file for the "medical device system"
 
mihzago

mihzago

Trusted Information Resource
#5
#5
In a normal world (i.e., before the MDR), this would be at most class I or maybe even not a medical device.
The feature "Notifications when he need to "play" the activities/games" probably makes it a medical device. There may be other features.

Normally, again before MDR, this would be a Class I, and maybe you can make an argument that this is a Class I device because it doesn't really provide any information that can be used for treatment or diagnosis (as stated in Rule 11). So, I think you could make the argument for Class I.

To be conservative, you could just make the app part of the system as a Class IIa device.
 
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