Testing data

It matches FDA's test data concept in AI Act terms. For AI-enabled medical devices, MDCG 2025-6 explains how the AI Act data requirements relate to MDR and IVDR obligations.

Article 3 (32) AIA ‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the expected performance of that system before its placing on the market or putting into service.

MDCG 2025-6 / AIB 2025-1, Section II, Question 10 (citing Article 3(32) AIA)