Key result
The European Union has reclassified non-medical brain stimulation devices as class III under the Medical Device Regulation, imposing stricter regulations on them than on medical devices.
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The EU's reclassification of non-medical brain stimulation devices imposes significant regulatory burdens on manufacturers.
The European Union (EU) has recently reclassified non-medical devices “intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neural activity in the brain” as class III, the highest risk class of the Medical Device Regulation (MDR) [1]. It also laid down common specifications for these devices concerning unacceptable risks, safety measures, and related aspects [2]. The EU allows placing non-invasive brain stimulation (NIBS) devices for non-medical purposes on the market but imposes significant burdens on manufacturers; they are stricter regulated than devices for medical purposes (class IIa or IIb).
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Christoph Bublitz (2023) reported an editorial. Reclassification of non-medical brain stimulation devices was evaluated. The European Union has reclassified non-medical brain stimulation devices as class III under the Medical Device Regulation, imposing stricter regulations on them than on medical devices.
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