Compliance
CE-marked medical device AI
AI that qualifies as a CE‑marked medical device under EU MDR/IVDR.
Definition
AI software that, by its intended clinical purpose and effect on patient treatment or diagnosis, falls within the definition of a medical device and therefore must satisfy the EU Medical Device Regulation (MDR/IVDR) requirements, obtain CE marking, and comply with associated conformity assessment, clinical evaluation and post‑market surveillance obligations.
Related Terms
AI as a Medical Device (AIaMD)
SaMD that incorporates artificial intelligence or machine learning....
Software as a Medical Device (SaMD)
Software intended for medical purposes independent of hardware....
Administrative or operational AI
AI used for non‑clinical administrative or operational tasks....
AI Product
Commercial applications incorporating AI capabilities....
high-risk application
AI use in contexts that materially affect rights or safety....