Validation data

This AI Act term corresponds to what FDA guidance calls tuning data. It is not the same as design validation in the quality system, so documentation for AI devices should make clear which meaning is intended.

Article 3 (30) AIA ‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable parameters and its learning process in order, inter alia, to prevent underfitting or overfitting;

MDCG 2025-6 / AIB 2025-1, Section II, Question 10 (citing Article 3(30) AIA)