To mitigate the risks from high-risk AI systems placed or otherwise put into service on the Union market, certain mandatory requirements should apply, taking into account the intended purpose of the use of the system and according to the risk management system to be established by the provider. In particular, the risk management system should consist of a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system. This process should ensure that the provider identifies and analyses the risks to the health, safety and fundamental rights of the persons who may be affected by the system in light of its intended purpose, including the possible risks arising from the interaction between the AI system and the environment within which it operates, and accordingly adopts suitable risk management measures in the light of state of the art.