Article 6 of the AI Act defines the criteria for an AI system to be classified as high-risk. According to paragraph 1(b), an AI system is considered high-risk if it is intended to be used as a safety component of the medical device or IVD, or the AI system is itself a product where the risk of the medical device or IVD requires Notified Body review per the MDR or IVDR, respectively. Therefore, an AI-enabled medical device or IVD, which requires Notified Body involvement, would likely be categorized as a high-risk AI system. Exceptions may exist in the rare situation where a higher-risk medical device or IVD employs AI that is not a safety component of the device…
