IMDRF N88 Good Machine Learning Practice for Medical...

What does P5 require?

Accepted methods are used to develop reference standards so that clinically relevant, well characterised data is collected and the limitations of the reference standard are understood; the choice is documented against the intended use and assessed for suitability in the intended use environment, accepted reference standards that demonstrate robustness and generalisability are used where available, and selection rests on broad consensus and appropriate expertise.

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

P1 Understand the intended use deeply and bring multi-disciplinary expertise across the life cycle
P10 Monitor deployed models and manage re-training risks
P2 Apply good software engineering, device design and security practice throughout
P3 Evaluate clinically with datasets representative of the intended patient population
P4 Keep training and test datasets independent
P6 Tailor model choice and design to the data and the intended use
P7 Assess the human-AI team in the intended use environment, not the device alone
P8 Test performance under clinically relevant conditions, independent of training data

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