01/10/2026
Before you can prove SaMD is safe and effective, you need to be clear about one thing: what is it actually meant to do?
That’s the intended purpose.
It defines:
• what the software does
• who it is for
• who should use it
• the clinical purpose it supports
Why does that matter?
Because it helps shape everything that follows — from medical device status and risk classification to evidence, testing and ongoing monitoring.
A clear intended purpose sets the direction for the entire regulatory journey.