IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)
Section 3: Guiding principles – IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)

IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) P9: Give users clear, essential information

What does P9 require?

The intended audience, whether clinicians or patients, receives clear, contextually relevant information suited to its needs: intended use and indications, benefits and risks, performance for appropriate subgroups, study methodology, characteristics of the training and test data, acceptable inputs, known limitations, how to interpret the user interface, how the model fits the clinical workflow and, as far as possible, the basis for its output; users are told the scope and timing of modifications and updates and given a way to raise product concerns with the manufacturer.

Maintained by Gerard Blokdyk

Other controls in Section 3: Guiding principles – IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.