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 a...

Full description

Bibliographic Details
Main Authors: Andrzej Grzybowski, Piotr Brona
Format: Article
Language:English
Published: Adis, Springer Healthcare 2023-01-01
Series:Ophthalmology and Therapy
Subjects:
Online Access:https://doi.org/10.1007/s40123-023-00652-w