AI Act Compliance for Manufacturing & Industry
Robotics, quality control and safety components — regulated under the AI Act
Practical guidelines for manufacturing companies and industrial organizations to comply with the EU AI Act and Machinery Regulation.
View the compliance checklist
Why Take Action Now?
The AI Act has major impact on the manufacturing sector
August 2025
First obligations for AI as safety component in machines and production systems
Safety Component = High-risk
AI affecting machine safety falls under the strictest AI Act and Machinery Regulation
Fines up to €35 million
Or 7% of global annual turnover — plus CE marking withdrawal for non-compliance
CE Marking Obligation
AI safety components require conformity assessment and European market access
High-risk AI in Manufacturing & Industry
These AI applications fall under strict AI Act requirements
Robotics & Cobots
Industrial robots and collaborative robots with AI control — worker safety is paramount.
Quality Control AI
Vision AI for product inspection and quality monitoring — impact on product liability and safety.
Predictive Maintenance
AI predicting machine maintenance and preventing production downtime — safety-relevant for critical components.
Process Optimization & Safety
AI systems optimizing production processes with direct impact on worker and product safety.
Specific Challenges for Manufacturing
The AI Act brings unique compliance questions for the industrial sector
Machinery Regulation Integration
How does AI Act compliance fit into existing CE marking processes? What are the overlaps with the new Machinery Regulation?
Safety Component Definition
When is AI a "safety component"? The classification determines whether you must meet the strictest requirements.
OT/IT Convergence
Operational technology with AI requires a different approach than office IT. How do you document embedded AI in machines?
Legacy Machines with AI Retrofit
Existing machines are increasingly equipped with AI. Who is responsible for compliance with retrofits?
Supply Chain Responsibility
Complex supply chains with multiple AI components. Who is provider, who is deployer?
Workplace Safety & AI
AI monitoring or protecting workers — where is the line between safety and surveillance?
AI Act Compliance Roadmap
Practical steps for manufacturing companies
AI Inventory
2-4 weeksMap all AI systems in machines and production processes. Including embedded AI and retrofits.
Risk Classification
1-2 weeksDetermine per system whether it is a safety component and whether it falls under high-risk.
Gap Analysis
3-6 weeksCompare current CE documentation and safety processes with AI Act and Machinery Regulation.
Remediation
3-12 monthsImplement technical documentation, risk management, testing and conformity assessment.
Ongoing Monitoring
OngoingSet up processes for post-market surveillance and periodic safety reviews.
What Makes Manufacturing AI Different?
Sector-specific considerations
Machinery Regulation + AI Act
Manufacturing AI falls under two legislative frameworks with their own conformity requirements
Physical Safety
AI decisions have direct physical impact on workers and products
CE Marking Requirement
Without AI Act compliance no CE marking — no access to the European market
Post-market Surveillance
Manufacturers must continue to monitor AI systems for safety after market introduction