Medical device software "ePROs" - significant change?


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We have a medical device software composed of a webapp (for the healthcare professionals) and a Mobile app for the patients which is basically just a way for them to see their therapy plan. So for the moment we do not collect any information from the patient with the Mobile App.
However, we would like to introduce a functionality to collect electronically Patient Collected Outcomes (ePROs) using the mobile app. So in that case, the mobile App will be collecting data from the patient.
Would be considered as a significant change according to the MDR ? Can we say that it changes the "intended use" of our product?
Thank you !


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This is another regulatory question that falls in pretty gray areas and that's why I think folks are a bit hesitant to reply. There may be other relevant information that we don't know and without which may lead to an improper response. For example, we don't know the software / device classification and don't know what you're going to do with the data.

The conservative approach would probably be "yes" it's a significant change. And it probably introduces a higher level of security requirements.

I would suggest you seek out (paid) regulatory guidance with someone who has regulatory experience with this type of device / software.
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