Is my AI a medical device?
Whether your AI software is regulated comes down to intended purpose and whether its output informs a clinical decision — not the technology. This is the first and most consequential question for any medical-AI team, because it determines every obligation that follows.
Run this assessment free →What makes software a medical device
Under EU MDR and MDCG 2019-11, software qualifies as medical device software (MDSW) when it provides information used for diagnostic or therapeutic purposes. The FDA applies a parallel Software as a Medical Device (SaMD) framework. The decisive factor is the intended purpose you state and the role the output plays in a clinical decision.
The wellness vs medical line
General wellness tools that don't influence diagnosis or treatment typically fall outside device regulation. But the boundary is narrower than most teams assume: software that 'supports' a clinical decision often crosses into regulated territory. Engineering the intended-purpose wording to avoid a class is the most common mistake — reviewers see through it immediately.
Why intended purpose is everything
The intended-purpose statement is the single most load-bearing sentence in your regulatory file. It drives qualification, classification, the evidence you need and the obligations you carry. Getting it precise — neither over- nor under-claiming — is the foundation of a defensible position.