Approval and Certification of Ophthalmic AI Devices in the European Union.

Abstract

Artificial intelligence (AI)-based medical devices are already commercially available in Europe. The regulations surrounding the introduction and use of medical AI devices in the European Union (EU) are different to those in the USA, and the specifics of European legislature in medical AI are not commonly known. European law classifies medical devices into four classes: I, IIa, IIb, and III, depending on the perceived risk level of the device. Medical devices are certified under independent nong