Currently, there is a push to deregulate artificial intelligence (AI) products within the

European Union (EU), including AI in medical devices and in-vitro diagnostics medical devices

(IVDMDs). The proposed changes in the AI Act mean that these medical AI products would not

be mandated to be subjected to human oversight. Additional risks inherent in the use of AI,

such as discriminatory bias, autonomous acting, spreading of misinformation, and model

drifting, will also no longer be covered by the regulation. EMSA opposes this push, as the

precautionary principle should always be applied in medicine, and this is a clear patient

safety risk. Therefore, we call upon legislators to ensure that medical devices and IVDMDs are

held to the highest standards and kept within the scope of the AI Act.