Artificial Intelligence-Based Medical Devices for Diabetic Retinopathy Screening in the European Union

CE-certified AI systems for DR detection represent a diverse and rapidly evolving landscape. While substantial progress has been made in regulatory classification and validation efforts, evidence remains heterogeneous, particularly for STDR detection and real-world implementation. Future research should prioritize consistent reporting standards, evaluation of multimodal approaches, and studies addressing real-world effectiveness to support safe and equitable deployment under the evolving EU regulatory framework.