The new regulation of non-medical neurotechnologies in the European Union: overview and reflection.

IF 2.5 2区哲学 Q1 ETHICS

Journal of Law and the Biosciences Pub Date : 2024-09-25 eCollection Date: 2024-07-01 DOI:10.1093/jlb/lsae021

Christoph Bublitz, Sjors Ligthart

引用次数: 0

Abstract

The regulation of neurotechnologies for non-medical purposes such as enhancement, gaming, or well-being is a topic of ongoing controversy. Without much attention, the European Union addressed it by two implementing regulations to the Medical Device Regulation (MDR) for non-invasive brain stimulation devices, passed in December 2022. This paper presents main aspect of these regulations and the conditions for placing non-medical neurodevices on the EU market, especially the risk threshold and the requirement for pre-market certification. It also provides a first critical comment on selected aspects and the unclear situation regarding research only devices which has alarmed the European neurotechnology sector.

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欧盟对非医疗神经技术的新规定：概述与思考。

对用于非医疗目的（如增强功能、游戏或保健）的神经技术的监管是一个一直存在争议的话题。欧盟于 2022 年 12 月通过了针对非侵入性脑部刺激设备的《医疗设备法规》（MDR）的两项实施细则，但并未引起广泛关注。本文介绍了这些法规的主要内容以及将非医疗神经刺激设备投放欧盟市场的条件，尤其是风险阈值和上市前认证要求。此外，本文还对某些方面进行了首次评论，并对仅用于研究的设备的不明确情况进行了评论，这引起了欧洲神经技术行业的警觉。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Law and the Biosciences Medicine-Medicine (miscellaneous)

CiteScore

7.40

自引率

5.90%

发文量

审稿时长

13 weeks

期刊介绍： The Journal of Law and the Biosciences (JLB) is the first fully Open Access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard University Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. The Journal contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.