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 › Article › Academic › peer-review

Original language	English
Pages (from-to)	103-108
Number of pages	6
Journal	Brain stimulation
Volume	18
Issue number	2
Early online date	21 Jan 2025
DOIs	https://doi.org/10.1016/j.brs.2025.01.012
Publication status	Published - 1 Mar 2025

Keywords

EU regulation
Medical device regulation
Reclassification
TMS
Transcranial brain stimulation
tDCS

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10.1016/j.brs.2025.01.012Licence: CC BY-NC

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

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keywords = "EU regulation, Medical device regulation, Reclassification, TMS, Transcranial brain stimulation, tDCS",

author = "Andrea Antal and Sack, {Alexander T.} and Bergmann, {Til Ole} and Jovana Bjekic and Filipovic, {Sa{\v s}a R.} and Ana Ganho-{\'A}vila and Vera Moliadze and Nitsche, {Michael A} and Simone Rossi and Teresa Schuhmann and Hartwig Siebner and Walter Paulus and Chris Baeken",

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doi = "10.1016/j.brs.2025.01.012",

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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

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 et al.
In: Brain stimulation, Vol. 18, No. 2, 01.03.2025, p. 103-108.

Research output: Contribution to journal › Article › Academic › peer-review

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AU - Antal, Andrea

AU - Sack, Alexander T.

AU - Bergmann, Til Ole

AU - Bjekic, Jovana

AU - Filipovic, Saša R.

AU - Ganho-Ávila, Ana

AU - Moliadze, Vera

AU - Nitsche, Michael A

AU - Rossi, Simone

AU - Schuhmann, Teresa

AU - Siebner, Hartwig

AU - Paulus, Walter

AU - Baeken, Chris

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KW - Transcranial brain stimulation

KW - tDCS

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