Can a software feature be labeled as RUO or performance evaluation only within a medical device software?

Question

Is it possible for one feature within a software product to be labeled as Research Use Only (RUO) or for performance evaluation only, while the rest of the software is a medical device? The feature would have relevant labels and would only be accessible to a limited number of labs, not to normal users.

Dr. Oliver Eidel · Accepted Answer

If you use a strictly separated modular concept, this might be possible. A software device can include modules that are themselves medical devices, sometimes even from different legal manufacturers. The same principle could apply if a module is not yet on the market and is only used in a performance study.
Labelling must be unambiguous at the module level and access should be restricted to participants in the performance investigation. Alignment with your Notified Body is highly recommended.

Answer

From my experience in other medical device fields (non-IVD), having a single feature labeled as RUO or for performance evaluation only within a medical device software is not common practice. Devices typically have a single label. If you switch on the performance study only feature, the device label should reflect that change. I would recommend asking your Notified Body for their opinion on this setup.

Can a software feature be labeled as RUO or performance evaluation only within a medical device software?

2 Answers

Keep reading

Is internally used diagnostic software considered a medical device under MDR?

Clinical Evaluation Report

How to Document Separate Medical Device Software Components