The European Society for Brain Stimulation opposes EU reclassification of TMS and tDCS, claiming a flawed safety assessment

Manifesto: Opposition to EU Reclassification of TMS and tDCS equipment to Class III devices based on flawed evidence (European Society for Brain Stimulation): It has recently come to our attention that the EU has reclassified the NIBS equipments including rTMS and tDCS, as Class III devices, the category of highest risk, similar to invasive treatments, such as deep-brain stimulation implants. This reclassification has a major impact on our field, not only for manufacturers, but also for researchers, clinicians and patients and we judge this reclassification a mistake. First, the evidential basis for this change is a flawed assessment of the safety literature. Second, the consultation process has occurred without input from specialists or stakeholders professionally active in the field of NIBS. Neither the ESBS nor National Societies of Brain Stimulation nor individual experts within the European NIBS community were consulted on this change. .. Although this new reclassification currently refers only to “products without an intended medical purpose”, the evidence adduced about the risks and adverse effects of rTMS and TES, — which serves as the justification for this reclassification‑, is gravely flawed. The EU has apparently assessed that NIBS poses a greater risk to patients’ safety than previously thought. This assessment is based on incorrect statements about rTMS and low intensity TES that are contradictory to the available scientific evidence, and many of the s...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Technology & Innovation brain stimulation EU European Society for Brain Stimulation neurostimulation rTMS tDCS Source Type: blogs