Antal, Andrea and Ganho-Avila, Ana and Assecondi, Sara and Barbour, Tracy and Bjekic, Jovana and Blumberger, Daniel M. and Bolognini, Nadia and Brunelin, Jerome and Chanes, Lorena and Dale, Matthew and Dubbioso, Raffaele and D'Urso, Giordano and Filipcic, Igor and Filipovic, Sasa R. and Hirnstein, Marco and Konings, Femke and Langguth, Berthold and Leocani, Letizia and Sorkhabi, Majid Memarian and Mulder, Marc and Nikander, Mika and Nowak, Rafal and Oliviero, Antonio and Onarheim, Balder and O'Shea, Jacinta and Pallanti, Stefano and Rachid, Fady and Rajao-Saraiva, Joana and Rossi, Simone and Sack, Alexander T. and Sauvaget, Anne and van der Scheer, Rik and Schellhorn, Klaus and Soria-Frisch, Aureli and Szekely, David and Tankisi, Hatice and Taylor, Paul C. J. and Tendolkar, Indira and Uusitalo, Susanne and Baeken, Chris (2024) 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. CLINICAL NEUROPHYSIOLOGY, 163. pp. 280-291. ISSN 1388-2457, 1872-8952
Full text not available from this repository. (Request a copy)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. (c) 2024 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | OVER-THE-COUNTER; ENGINEERING PRINCIPLES; PRESCRIPTION DEVICES; INDUSTRY STANDARDS; WELLNESS; STATUTES; SAFETY; Medical device regulation; Brain stimulation; Reclassification |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Jul 2025 10:18 |
| Last Modified: | 24 Jul 2025 10:18 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65721 |
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