Hi Neb2,

From my experience, you might have two functionally similar devices but they may have different risks. For example, an infusion pump that is used for normal IV infusion may be considered a non significant risk, while as an infusion pump used for epidural anesthesia is Considered a SR since it might cause significant risk.

Therefore, I usually look at the risk profile based on the intended use, use environment and user population.

– Fady Khalla