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

4 Citations (Scopus)

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 - Mar 2025

Keywords

EU regulation
Medical device regulation
Reclassification
tDCS
TMS
Transcranial brain stimulation

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

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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 et al.
In: Brain Stimulation, Vol. 18, No. 2, 03.2025, p. 103-108.

Research output: Contribution to journal › Letter › 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

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

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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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 - Medical device regulation

KW - Reclassification

KW - tDCS

KW - TMS

KW - Transcranial brain stimulation

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U2 - 10.1016/j.brs.2025.01.012

DO - 10.1016/j.brs.2025.01.012

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ER -

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

Keywords

Access to Document

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