Hello,
This is more of a survey/curiosity but are medical device softwares currently being classified as class I under the MDR ? Or are notified body really against it?
For instance, we have a sensor that sends data to a mobile application to present/visualise the data.
At the therapist uses the data is considered as " information which is used to take decisions with diagnosis or therapeutic purposes" then the mobile app should be a class IIa correct?
It just seems like a very regulatory burden.
This is more of a survey/curiosity but are medical device softwares currently being classified as class I under the MDR ? Or are notified body really against it?
For instance, we have a sensor that sends data to a mobile application to present/visualise the data.
At the therapist uses the data is considered as " information which is used to take decisions with diagnosis or therapeutic purposes" then the mobile app should be a class IIa correct?
It just seems like a very regulatory burden.