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

Neuroplasticity, Synchrony & Cognition

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

Access to Document

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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title = "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 = "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",

year = "2025",

month = mar,

day = "1",

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

language = "English",

volume = "18",

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journal = "Brain stimulation",

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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

TY - JOUR

T1 - 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

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

PY - 2025/3/1

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KW - EU regulation

KW - Medical device regulation

KW - Reclassification

KW - TMS

KW - Transcranial brain stimulation

KW - tDCS

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DO - 10.1016/j.brs.2025.01.012

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JO - Brain stimulation

JF - Brain stimulation

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