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Approval and Certification of Ophthalmic AI Devices in the European Union
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 co...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10011240/ https://www.ncbi.nlm.nih.gov/pubmed/36652171 http://dx.doi.org/10.1007/s40123-023-00652-w |
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author | Grzybowski, Andrzej Brona, Piotr |
author_facet | Grzybowski, Andrzej Brona, Piotr |
author_sort | Grzybowski, Andrzej |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10011240 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-100112402023-03-15 Approval and Certification of Ophthalmic AI Devices in the European Union Grzybowski, Andrzej Brona, Piotr Ophthalmol Ther Commentary 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. Springer Healthcare 2023-01-18 2023-04 /pmc/articles/PMC10011240/ /pubmed/36652171 http://dx.doi.org/10.1007/s40123-023-00652-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Commentary Grzybowski, Andrzej Brona, Piotr Approval and Certification of Ophthalmic AI Devices in the European Union |
title | Approval and Certification of Ophthalmic AI Devices in the European Union |
title_full | Approval and Certification of Ophthalmic AI Devices in the European Union |
title_fullStr | Approval and Certification of Ophthalmic AI Devices in the European Union |
title_full_unstemmed | Approval and Certification of Ophthalmic AI Devices in the European Union |
title_short | Approval and Certification of Ophthalmic AI Devices in the European Union |
title_sort | approval and certification of ophthalmic ai devices in the european union |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10011240/ https://www.ncbi.nlm.nih.gov/pubmed/36652171 http://dx.doi.org/10.1007/s40123-023-00652-w |
work_keys_str_mv | AT grzybowskiandrzej approvalandcertificationofophthalmicaidevicesintheeuropeanunion AT bronapiotr approvalandcertificationofophthalmicaidevicesintheeuropeanunion |