This recital applies to high-risk AI systems integrated into products regulated under the EU New Legislative Framework.
Furthermore, when a high-risk AI system that is a safety component of a product covered by Union harmonisation legislation based on the New Legislative Framework is subject to the requirements of that Union harmonisation legislation, the requirements of this Regulation regarding risk management, data governance, technical documentation, record-keeping, transparency, information provided to users, human oversight, accuracy, robustness and cybersecurity should be integrated into the conformity assessment procedures applicable under that Union harmonisation legislation.
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.