AI systems that constitute safety components of products governed by Annex I harmonisation legislation are classified as high-risk regardless of whether they fall within an Annex III domain. Annex I covers Union harmonisation legislation including the Machinery Regulation, the Medical Devices Regulation, the Radio Equipment Directive, civil aviation safety regulations, motor vehicle type-approval regulations, and marine equipment requirements.

A safety component is an AI system that, if it malfunctions or fails, can endanger the health or safety of persons. The determination requires both a product-level analysis (is the product governed by Annex I legislation?) and a component-level analysis (does the AI system perform a safety function within that product?). An AI system that optimises an industrial robot’s trajectory is a safety component; an AI system that schedules maintenance for the same robot may not be.

For Annex I safety components, the AI Act conformity assessment must coordinate with the product-level conformity assessment under the relevant harmonisation legislation. The Conformity Assessment Coordinator documents both assessments and their interaction.

Key outputs

• Product-level Annex I legislation identification
• Component-level safety function determination
• Coordinated conformity assessment planning
• Module 6 AISDP documentation