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. 2024 Jul:163:280-291.
doi: 10.1016/j.clinph.2024.03.039. Epub 2024 Apr 10.

The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper

Andrea Antal  1 , Ana Ganho-Ávila  2 , Sara Assecondi  3 , Tracy Barbour  4 , Jovana Bjekić  5 , Daniel M Blumberger  6 , Nadia Bolognini  7 , Jerome Brunelin  8 , Lorena Chanes  9 , Matthew Dale  10 , Raffaele Dubbioso  11 , Giordano D'Urso  12 , Igor Filipcic  13 , Saša R Filipović  14 , Marco Hirnstein  15 , Femke Konings  16 , Berthold Langguth  17 , Letizia Leocani  18 , Majid Memarian Sorkhabi  19 , Marc Mulder  20 , Mika Nikander  21 , Rafal Nowak  22 , Antonio Oliviero  23 , Balder Onarheim  24 , Jacinta O'Shea  25 , Stefano Pallanti  26 , Fady Rachid  27 , Joana Rajão-Saraiva  28 , Simone Rossi  29 , Alexander T Sack  30 , Anne Sauvaget  31 , Rik van der Scheer  32 , Klaus Schellhorn  33 , Aureli Soria-Frisch  34 , David Szekely  35 , Hatice Tankisi  36 , Paul Cj Taylor  37 , Indira Tendolkar  38 , Susanne Uusitalo  39 , Chris Baeken  40
Affiliations

The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper

Andrea Antal et al. Clin Neurophysiol. 2024 Jul.

Abstract

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment.

Keywords: Brain stimulation; Medical device regulation; Reclassification.

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Conflict of interest statement

Conflict of interest

AA has received consulting fees from Neurocare (Germany), from Savir GmbH, (Germany), and from Elsevier, she is a paid advisor by Electromedical Products International, (USA), has non-financial support from Sooma, Member of the advisory board bei PlatoScience. She is the Vice President of the European Brain Stimulation Society and member at large at the Europa, Middle East, Africa Chapter of the International Federation of Clinical Neurophysiology.

ATS is chief scientific advisor for PlatoScience Medical, scientific advisor for Alpha Brain Technologies, Founder and CEO of Neurowear Medical, director of the International Clinical TMS Certification Course (https://www.tmscourse.eu). He also received equipment support from MagVenture, Magstim, and Deymed Diagnostics.

AGA has non-financial support from Flow Neuroscience and Sooma.

ASF has been involved as Project Manager in the development of the first Neuroelectrics’ prototypes for EEG and NIBS. Moreover has received funding for the realization of research projects related with EEG from Neuroelectrics.

BL received honoraria for consultancy and speakers’ fees from ANM, AstraZeneca, Autifony Therapeutics, Decibel Therapeutics, Desyncra, Gerson Lehmanns Group, Lundbeck, Merz, MagVenture, Medical Tribune, Neurolite, Neuromod, Novartis, Pfizer, Rovi, Schwabe, Sea Pharma, Servier, Sonova and Sound Therapeutics.

AO is cofounder of Neurek SL.

SA is named inventor on a patent application (publication number WO/2022/106850) jointly submitted by the University of Birmingham and Dalhousie University, titled “Improving cognitive function” RN works for Neuroelectrics, a company developing devices for EEG and NIBS.

MN works for Sooma Oy, a company developing devices for NIBS.

BO works for, and is a shareholder in, PlatoScience ApS, a company developing NIBS devices.

KS works for neuroConn GmbH and is a shareholder of Neurocare Group AG.

MMS and MD are employees of Magstim Co. Ltd, UK.

HT is a shareholder of QTMS Science Ltd.

The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Comment in

References

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