Andrea Antal, Ana Ganho-Ávila, Sara Assecondi, Tracy Barbour, Jovana Bjekić, Daniel M Blumberger, Nadia Bolognini, Jerome Brunelin, Lorena Chanes, Matthew Dale, Raffaele Dubbioso, Giordano D'Urso, Igor Filipcic, Saša R Filipović, Marco Hirnstein, Femke Konings, Berthold Langguth, Letizia Leocani, Majid Memarian Sorkhabi, Marc Mulder, Mika Nikander, Rafal Nowak, Antonio Oliviero, Balder Onarheim, Jacinta O'Shea, Stefano Pallanti, Fady Rachid, Joana Rajão-Saraiva, Simone Rossi, Alexander T Sack, Anne Sauvaget, Rik van der Scheer, Klaus Schellhorn, Aureli Soria-Frisch, David Szekely, Hatice Tankisi, Paul Cj Taylor, Indira Tendolkar, Susanne Uusitalo, Chris Baeken
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...
April 10, 2024: Clinical Neurophysiology: Official Journal of the International Federation of Clinical Neurophysiology