Chapter 6. AI and self-evolving behaviour: when is your software a safety function?

Does any software in your machinery make decisions that affect safety and do you know what that means for compliance?

The boundary between 'software feature' and 'safety function' has become a compliance-critical distinction under Regulation (EU) 2023/1230. If AI or adaptive software influences provides a safety function (e.g. stopping, speed, distance, or safety limits), mandatory third-party conformity assessment may apply under Annex I Part A. High-risk AI systems, under the EU AI Act, may also be subject to additional requirements integrated into the Machinery Regulation under the EU AI Act sectoral approach. This assessment helps you evaluate your exposure.

Country

Your name

Company

Q1. Are you aware that machinery incorporating AI or machine learning for safety-relevant functions is classified as high-risk under Regulation (EU) 2023/1230 and requires mandatory Notified Body certification?

Q2. Do you know that your AI-equipped machinery may also fall under the EU AI Act as a high-risk AI system, with relevant AI Act requirements being integrated into the Machinery Regulation?

Q3. Does any software in your machinery make decisions that directly affect stopping, speed control, distance limits, or other safety-critical functions?

Q4. Do you log AI safety-related decisions, and retain those logs for at least one year, as required by Annex III for software-based safety systems?

Q5. Have you defined and documented the behavioural boundaries within which your AI system must operate and validated that the system cannot exceed those limits?

Q6. How would you describe the role of AI or adaptive software in your current or planned machinery portfolio?