Fig. 3: Risk classification process following the EU AI Act and EU Medical Devices Regulation.

The figure shows a flowchart for the risk classification of artificial intelligence (AI)-enabled medical devices under the Medical Devices Regulation (MDR) and the AI Act. It begins with the question: “Is the technology an artificial intelligence system?” If the answer is “No,” it falls outside the scope of the AI Act. If “Yes,” it proceeds to check if the intended purpose is within the scope of medical devices. A “No” here means it is outside the scope of MDR. If both answers are “Yes,” the flowchart notes that the vast majority of software as a medical device is classified as risk category IIa or higher. Medical devices with risk class IIa or higher are high-risk artificial intelligence systems. This means that these AI-enabled medical device require Conformité Européene (CE) marking through a decentralized notified body. The boxes positioned on the left side indicate the specific section of the MDR or AI Act that informs that specific step. Source: authors’ own creation.