Compliance
AI as a Medical Device (AIaMD)
SaMD that incorporates artificial intelligence or machine learning.
Definition
A subset of SaMD that includes artificial intelligence or machine learning methods as part of its functionality; regulatory assessment focuses on intended purpose, performance, and lifecycle risks rather than the mere presence of AI labels.
Related Terms
Software as a Medical Device (SaMD)
Software intended for medical purposes independent of hardware....
CE-marked medical device AI
AI that qualifies as a CE‑marked medical device under EU MDR/IVDR....
Health AI Systems
AI technologies processing health data or supporting health decisions....
Large language models and general-purpose AI systems
General-purpose models not tailored to a single clinical task....
AI for Health
AI applications in healthcare delivery, research, and public health....