Product Manufacturer

Product Manufacturer in the AI regulation context refers to an entity that integrates an AI system into a product covered by Union harmonisation legislation and places that product on the market under their own name or trademark.

EU AI Act Implications:

• Provider Status (Article 25): When a product manufacturer places an AI system on the market together with their product under their own name, they become the "provider" of that AI system with all associated obligations
• Joint Responsibility: The original AI provider and product manufacturer may have joint compliance responsibilities
• Safety Component: If the AI system is a "safety component" of the product, the product manufacturer has particular obligations

Union Harmonisation Legislation: Products covered by existing EU product safety laws that may integrate AI include:

• Machinery (Machinery Regulation)
• Medical devices (MDR, IVDR)
• Toys (Toy Safety Directive)
• Radio equipment (RED)
• Civil aviation
• Motor vehicles
• Rail systems
• Marine equipment

Obligations:

• Ensure the AI system meets AI Act requirements applicable to their product
• Conduct conformity assessment (which may include AI-specific assessment)
• Maintain technical documentation for both product and AI system
• Cooperate with market surveillance authorities

Practical Example: A car manufacturer integrating an AI-based driver assistance system becomes the provider of that AI system when placing the vehicle on the EU market.