AIRiskAware
AI Governance Glossary
Regulation

What Is Product Manufacturer?

Product Manufacturer is under the EU AI Act, the manufacturer of a product in which a high-risk AI system is used as a safety component, where the product is covered by the EU harmonisation legislation listed in Annex I and placed on the market under the manufacturer's name or trademark.

Definition

Product Manufacturerunder the EU AI Act, the manufacturer of a product in which a high-risk AI system is used as a safety component, where the product is covered by the EU harmonisation legislation listed in Annex I and placed on the market under the manufacturer's name or trademark.

Where AI is embedded as a safety component of a regulated product (for example, machinery or a medical device), the product manufacturer is treated as the provider of the AI system and takes on the provider's obligations. This keeps AI accountability aligned with the existing product-safety regime rather than creating a separate, parallel set of duties.

Source: EU AI Act, Article 25(3) and Annex I

Plain-language explanation

Where AI is embedded as a safety component of a regulated product (for example, machinery or a medical device), the product manufacturer is treated as the provider of the AI system and takes on the provider's obligations. This keeps AI accountability aligned with the existing product-safety regime rather than creating a separate, parallel set of duties.

Primary source: EU AI Act, Article 25(3) and Annex I

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