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 !
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 !