Europe needs new regulatory framework for wellness neurotech devices — policy analysis and recommendations
Summary
A policy analysis published by the Centre for Governance of AI (CfG) examined the regulatory gap for consumer wellness neurotechnology devices in Europe — EEG headbands, neurostimulation wearables, and neural feedback apps that claim health benefits but fall below the threshold for CE mark as medical devices. The paper documents 47 consumer neurotech products making health claims in European markets without regulatory oversight, and proposes a proportionate risk-based framework distinguishing general wellness devices from those making therapeutic claims.
Why it matters
Consumer neurotech has outpaced European regulation — 47 products making health claims without CE mark oversight represents both a consumer safety risk and a commercial uncertainty for legitimate companies. A clear EU regulatory framework for wellness neurotech would level the playing field between compliant medical device companies and unregulated wellness claims, and provide consumer confidence in neurotech products purchased over-the-counter.
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