This applies to AI systems integrated into products regulated under EU harmonization legislation, such as machinery, toys, medical devices, and vehicles, where third-party conformity assessment is mandatory.
Regarding AI systems that act as safety components for products covered by specific Union harmonization legislation, these must be classified as high-risk if the product requires third-party conformity assessment.
As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation legislation listed in an annex to this Regulation, it is appropriate to classify them as high-risk under this Regulation if the product concerned undergoes the conformity assessment procedure with a third-party conformity assessment body pursuant to that relevant Union harmonisation legislation. In particular, such products are machinery, toys, lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, appliances burning gaseous fuels, medical devices, in vitro diagnostic medical devices, automotive and aviation.