Note of concern regarding the sources of scientific evidence used to justify the Reclassification of Non-Invasive Brain Stimulation (NIBS) Devices without an intended medical purpose into Class III

Andrea Antal; Alexander T. Sack; Til Ole Bergmann; Jovana Bjekic; Saša R. Filipovic; Ana Ganho-Ávila; Vera Moliadze; Michael A. Nitsche; Simone Rossi; Teresa Schuhmann; Hartwig Siebner; Walter Paulus; Chris Baeken

doi:10.1016/j.brs.2025.01.012

Note of concern regarding the sources of scientific evidence used to justify the Reclassification of Non-Invasive Brain Stimulation (NIBS) Devices without an intended medical purpose into Class III

Andrea Antal^*, Alexander T. Sack, Til Ole Bergmann, Jovana Bjekic, Saša R. Filipovic, Ana Ganho-Ávila, Vera Moliadze, Michael A. Nitsche, Simone Rossi, Teresa Schuhmann, Hartwig Siebner, Walter Paulus, Chris Baeken

^*Corresponding author for this work

Research output: Contribution to journal › Comment/debate › Research › peer-review

Original language	English
Journal	Brain Stimulation
Volume	18
Issue number	2
Pages (from-to)	103-108
Number of pages	6
ISSN	1935-861X
DOIs	https://doi.org/10.1016/j.brs.2025.01.012
Publication status	Published - 2025

Keywords

EU regulation
Medical device regulation
Reclassification
tDCS
TMS
Transcranial brain stimulation

Access to Document

10.1016/j.brs.2025.01.012

Cite this

Antal, A., Sack, A. T., Bergmann, T. O., Bjekic, J., Filipovic, S. R., Ganho-Ávila, A., Moliadze, V., Nitsche, M. A., Rossi, S., Schuhmann, T., Siebner, H., Paulus, W., & Baeken, C. (2025). Note of concern regarding the sources of scientific evidence used to justify the Reclassification of Non-Invasive Brain Stimulation (NIBS) Devices without an intended medical purpose into Class III. Brain Stimulation, 18(2), 103-108. https://doi.org/10.1016/j.brs.2025.01.012

Note of concern regarding the sources of scientific evidence used to justify the Reclassification of Non-Invasive Brain Stimulation (NIBS) Devices without an intended medical purpose into Class III. / Antal, Andrea; Sack, Alexander T.; Bergmann, Til Ole; Bjekic, Jovana; Filipovic, Saša R.; Ganho-Ávila, Ana; Moliadze, Vera; Nitsche, Michael A.; Rossi, Simone; Schuhmann, Teresa; Siebner, Hartwig; Paulus, Walter; Baeken, Chris.

In: Brain Stimulation, Vol. 18, No. 2, 2025, p. 103-108.

Research output: Contribution to journal › Comment/debate › Research › peer-review

Antal, A, Sack, AT, Bergmann, TO, Bjekic, J, Filipovic, SR, Ganho-Ávila, A, Moliadze, V, Nitsche, MA, Rossi, S, Schuhmann, T, Siebner, H, Paulus, W & Baeken, C 2025, 'Note of concern regarding the sources of scientific evidence used to justify the Reclassification of Non-Invasive Brain Stimulation (NIBS) Devices without an intended medical purpose into Class III', Brain Stimulation, vol. 18, no. 2, pp. 103-108. https://doi.org/10.1016/j.brs.2025.01.012

Antal, Andrea ; Sack, Alexander T. ; Bergmann, Til Ole ; Bjekic, Jovana ; Filipovic, Saša R. ; Ganho-Ávila, Ana ; Moliadze, Vera ; Nitsche, Michael A. ; Rossi, Simone ; Schuhmann, Teresa ; Siebner, Hartwig ; Paulus, Walter ; Baeken, Chris. / Note of concern regarding the sources of scientific evidence used to justify the Reclassification of Non-Invasive Brain Stimulation (NIBS) Devices without an intended medical purpose into Class III. In: Brain Stimulation. 2025 ; Vol. 18, No. 2. pp. 103-108.

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