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 nongovernment bodies, and some can even self-certify their compliance with EU standards. The European "open" approach is vastly different from the strict perspective of the FDA, as reflected by the number of available medical AI devices. The EU is currently in a transitory period between two regulations, further complicating the legislative landscape. The devices in question deal with extremely sensitive data, collecting, processing, and sending images and diagnoses over the internet. The EU approach puts a large burden of verifying the effectiveness and integrity of the AI device on the consumer, without giving consumers many tools to do that effectively. This highlights the need for effective legislation and oversight from governing bodies, as well as the need for understanding the legalities and limitations of AI devices for those implementing them in clinical practice.