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

Affiliations

• ¹ Department of Neurology, University Medical Center Göttingen, Göttingen. Germany. Electronic address: [email protected].
• ² Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal.
• ³ Centre for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto (TN), Italy.
• ⁴ Massachusetts General Hospital, Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
• ⁵ University of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation Belgrade, Serbia.
• ⁶ Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health and Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
• ⁷ Department of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCCS Istituto Auxologico Italiano, Milano, Italy.
• ⁸ CH Le Vinatier, Université Claude Bernard Lyon 1, CNRS, INSERM, Centre de Recherche en Neurosciences de Lyon CRNL, Bron, France.
• ⁹ Department of Clinical and Health Psychology-Institute of Neurosciences, Universitat Autònoma de Barcelona, Barcelone, Spain.
• ¹⁰ Magstim, Spring Gardens, Whitland, Carmarthenshire, SA34 0HR, UK.
• ¹¹ Neurophysiology Unit, Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples, Naples, Italy.
• ¹² Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples "Federico II", Naples, Italy.
• ¹³ Psychiatric Clinic 'Sveti Ivan', Zagreb, Croatia.
• ¹⁴ University of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation, Belgrade, Serbia.
• ¹⁵ Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.
• ¹⁶ Independent expert by experience contributor, Amsterdam, the Netherlands.
• ¹⁷ Chair of the German Society for Brain Stimulation in Psychiatry, Department of Psychiatry and Psychotherapy, Bezirksklinikum, University of Regensburg, Germany.
• ¹⁸ Experimental Neurophysiology Unit, Institute of Experimental Neurology-INSPE, San Raffaele Scientific Institute, Milan, Italy; Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
• ¹⁹ Magstim, Spring Gardens, Whitland, Carmarthenshire SA34 0HR, UK.
• ²⁰ Independent expert by experience contributor, The Hague, the Netherlands.
• ²¹ Sooma Oy, Helsinki, Finland.
• ²² Neuroelectrics, Barcelona, Catalonia, Spain.
• ²³ FENNSI Group, Hospital Nacional de PArapléjicos, SESCAM, Toledo, Spain; Center for Clinical Neuroscience - Hospital "Los Madroños", Brunete (Madrid), Spain.
• ²⁴ School of Psychology and Humanities, University of Central Lancashire, U.K.
• ²⁵ Department of Psychiatry, University of Oxford, U.K.
• ²⁶ Istituto di Neuroscienze (Italy) and Albert Einstein College of Medicine (NY. USA) Chair of ECNP Network on Neuromodulation.
• ²⁷ Private Practice, 7, place de la Fusterie, 1204, Geneva, Switzerland.
• ²⁸ Independent expert by experience contributor, Coimbra, Portugal.
• ²⁹ Siena Brain Investigation and Neuromodulation Lab (SiBIN Lab), Department of Medicine, Surgery and Neuroscience, University of Siena, Italy.
• ³⁰ Section Brain Stimulation and Cognition, Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University (UM); Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience (MHeNs), Brain+Nerve Centre, Maastricht University Medical Center (MUMC+), Center for Integrative Neuroscience (CIN), the Netherlands.
• ³¹ Department of Psychiatry, University Hospital of Nantes, France.
• ³² Independent Patient Representative Advisor in Adult, Child & Adolescent Psychiatry, Venlo, the Netherlands.
• ³³ neuroConn GmbH, Ilmenau, Germany.
• ³⁴ Neuroscience BU, Starlab Barcelona, Spain.
• ³⁵ Deputy Head of Neuromodulation Unit of Princess Grace Hospital Centre, Monaco.
• ³⁶ Head of the Europa, Middle East, Africa Chapter of the International Federation of Clinical Neurophysiology, Department of Clinical Neurophysiology, Aarhus University Hospital and Department of Clinical Institute, Aarhus University, Aarhus, Denmark.
• ³⁷ Department of Psychology, LMU Munich, Munich, Germany.
• ³⁸ Donders Institute for Brain, Cognition and Behavior, Department of Psychiatry, Radboud University Nijmegen, Netherlands.
• ³⁹ Philosophy (ethics), University of Oulu, Finland.
• ⁴⁰ Department of Head and Skin - Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent University, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Department of Psychiatry, Brussels, Belgium; Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, the Netherlands.