Safety component

The term matters because an AI system that is a safety component of a device covered by the MDR or IVDR can be a high-risk AI system when the device needs a notified body assessment. MDCG 2025-6 explains how the two sets of rules connect.

AIA Art 3(14) defines safety component as ‘a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property’.

MDCG 2025-6 / AIB 2025-1, Section I, Question 2, footnote 8 (citing Article 3(14) AIA)