Machine learning (ML)

For medical devices, the practical question with ML is how the model will change after release. FDA addresses planned changes through a predetermined change control plan, and in the EU an ML-based device is assessed under the MDR or IVDR and may also fall under the AI Act.

An application of artificial intelligence that is characterized by providing systems the ability to automatically learn and improve on the basis of data or experience, without being explicitly programmed.

FDA guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025), Section IV, Definitions