Recital 87
In addition, where a high-risk AI system that is a safety component of a product which falls within the scope of Union harmonisation legislation based on the New Legislative Framework is not placed on the market or put into service independently from the product, the product manufacturer defined in that legislation should comply with the obligations of the provider established in this Regulation and should, in particular, ensure that the AI system embedded in the final product complies with the requirements of this Regulation.
This Recital outlines the scope of the regulation concerning high-risk AI systems that are integrated into products covered by sector-specific legislation under the New Legislative Framework (NLF) in the European Union. The New Legislative Framework encompasses a set of rules for placing products on the EU market. It includes regulations such as directives for specific product categories, like machinery, medical devices, toys, etc. These directives establish requirements for the safety and conformity of products within their respective sectors.
The "product manufacturer" referred to here is the entity responsible for producing the final product, which includes an AI system as a safety component. This entity falls under the definition provided by the relevant sector-specific legislation within the New Legislative Framework.
So, in essence, the product manufacturers within the scope of the EU AI Act are those who produce products covered by sector-specific legislation under the New Legislative Framework, and these products incorporate high-risk AI systems as safety components. These manufacturers are obligated to ensure that the AI systems embedded in their final products comply with the requirements set forth by the EU AI Act.