From speculation to regulation: an evidence-based analysis of the EU reclassification of non-invasive brain...

In December 2022, the European Commission reclassified non-invasive brain stimulation (NIBS) devices without a medical purpose into the highest risk category (Class III) under Regulation (EU) 2022/2347, referring to 'available scientific evidence' on potential neurological risks. This article examines the evidentiary basis and regulatory implications of that decision. A systematic analysis of the five references submitted by six Member States showed that the list of side effects incorporated into the legal text was largely drawn from a single ethics-oriented publication not intended to assess clinical safety. None of the cited sources include empirical investigations of device safety or systematic reviews of adverse events. In contrast, an extensive body of clinical research comprising hundreds of randomized controlled trials and meta-analyses provides a detailed empirical account of the safety profile of NIBS techniques. The resulting framework places non-medical NIBS devices in the same category as highest-risk medical technologies, with observable effects manifesting. Furthermore, the codification of potential side effects in legally binding text may influence institutional and public perceptions, shaping research governance and ethics reviews. The paper concludes by recommending a regulatory approach that reflects user competence, evaluates risks according to probability, and integrates expert consultation to ensure consistency with evidence-based lawmaking.