4th International Conference on
AI in Healthcare, Industry & Regulatory Affairs
May 25–27, 2027 | Toronto, Canada
Four Points by Sheraton Toronto Hotel
Address: Mississauga, 6090 Dixie Road, Mississauga, ON, L5T 1A6, Canada
AIHIRA 2027
Medical Device Classification
Before regulatory approval, manufacturers need to determine what regulatory category their product falls into.
AI makes classification particularly interesting because the regulatory status can depend on:
- Intended use
- Medical purpose
- Risk to patients
- Clinical function
- Whether AI influences diagnosis
- Whether AI influences treatment
- Whether AI controls another medical device
- Software functionality
For example, an AI system that simply organizes administrative information may have very different regulatory implications from an AI system that detects cancer from medical images.