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

被引：0

作者：

Bublitz, Christoph ^{[1
]}

Ligthart, Sjors ^{[2
,3
]}

机构：

[1] Univ Hamburg, Fac Law, Ctr Law Digital Transformat, Rothenbaumchaussee 33, D-20148 Hamburg, Germany

[2] Univ Utrecht, Utrecht, Netherlands

[3] Tilburg Univ, Dept Criminal Law, NL-5000 LE Tilburg, Netherlands

来源：

JOURNAL OF LAW AND THE BIOSCIENCES | 2024年 / 11卷 / 02期

基金：

荷兰研究理事会;

关键词：

Medical Device Regulation; technology governance; enhancement; risk assessment; research and development; neuroscience; DEVICES;

D O I：

10.1093/jlb/lsae021

中图分类号：

B82 [伦理学（道德学）];

学科分类号：

摘要：

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.

引用

页数：15

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