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