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 af dette arbejde

Publikation: Bidrag til tidsskrift › Kommentar/debat › Forskning › peer review

Originalsprog	Engelsk
Tidsskrift	Brain Stimulation
Vol/bind	18
Udgave nummer	2
Sider (fra-til)	103-108
Antal sider	6
ISSN	1935-861X
DOI	https://doi.org/10.1016/j.brs.2025.01.012
Status	Udgivet - 2025

Adgang til dokumentet

10.1016/j.brs.2025.01.012

Citationsformater

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.
I: Brain Stimulation, Bind 18, Nr. 2, 2025, s. 103-108.

Publikation: Bidrag til tidsskrift › Kommentar/debat › Forskning › 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, bind 18, nr. 2, s. 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, 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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doi = "10.1016/j.brs.2025.01.012",

language = "English",

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journal = "Brain Stimulation",

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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

Y1 - 2025

KW - EU regulation

KW - Medical device regulation

KW - Reclassification

KW - tDCS

KW - TMS

KW - Transcranial brain stimulation

U2 - 10.1016/j.brs.2025.01.012

DO - 10.1016/j.brs.2025.01.012

M3 - Comment/debate

C2 - 39848538

AN - SCOPUS:85215935106

SN - 1935-861X

VL - 18

SP - 103

EP - 108

JO - Brain Stimulation

JF - Brain Stimulation

IS - 2

ER -