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

Abstract

Diabetic retinopathy (DR) remains a leading cause of preventable blindness, yet screening programs across Europe face persistent workforce and capacity constraints amid rising diabetes prevalence. Artificial intelligence (AI)-enabled screening platforms have been developed to support scalable DR detection; however, their regulatory status, validation approaches, and implementation readiness vary considerably. We conducted a targeted scoping review of 13 CE-certified AI systems for autonomous or