Non-Invasive Neuromodulation Products: Navigating the Regulatory Divide Between Consumer Wellness and Medical Devices in the UK and EU

Executive Summary

Non-invasive neuromodulation (NIM) represents rapidly evolving frontier in health technology, encompassing techniques such as Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), Transcutaneous Electrical Nerve Stimulation (TENS), and Transcutaneous Vagus Nerve Stimulation (tVNS). These methods modulate nervous system activity through external electrical or magnetic fields, offering a less intrusive alternative to surgical implants. The versatility of these technologies has led to their widespread adoption in both clinical environments for treating diagnosed medical conditions and in the consumer market for general wellness, cognitive enhancement, and performance optimisation.

The fundamental distinction determining whether a non-invasive neuromodulation product falls under the stringent medical device regulatory framework or the broader consumer wellness regulations is its...

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