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) P7: Assess the human-AI team in the intended use environment, not the device alone

What does P7 require?

The device is assessed within its intended use environment and clinical workflow, including how it interacts with clinicians, patients and caregivers, so that what is measured is how the human and the AI perform together; human factors such as user skill and expertise, understanding of outputs and limitations, potential for overreliance, level of autonomy and user error are addressed both in normal use and in misuse that could reasonably be foreseen.

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.

MCP endpointAll IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) controls