Consumer neuro devices within EU product safety law: Are we prepared for big tech ante portas?

Abstract

Previously confined to the distinct medical market, neurotechnologies are expanding rapidly into the consumer market, driven by technological advancements and substantial investments. While offering promising benefits, concerns have emerged regarding the suitability of existing legal frameworks to adequately address the risks they present. Against the background of an ongoing global debate on new policies or new ‘neurorights’ regulating neurotechnology, this paper delves into the regulation of consumer Brain-Computer Interfaces (BCIs) in the European Union (EU), focusing on the pertinent product safety legislation. The analysis will primarily examine the sector-specific product safety law for medical devices, the Medical Devices Regulation (MDR). It will meticulously delineate which consumer BCIs fall within its scope and are obliged to comply with the requirements outlined. The tech-based approach of Annex XVI MDR, coupled with recent amendments, show that the EU has adopted a forward-thinking rationale towards regulating health-related risks associated with consumer BCIs within existing EU medical devices legislation, while abstaining from over-regulating aspects therein that are beyond its core objectives. Supplementary, the paper will discuss developments in EU horizontal product safety law, regulating all consumer BCIs that are not subject to sector-specific product safety legislation. In their recently adopted General Product Safety Regulation (GPSR), the EU has introdu…