TY - JOUR
T1 - 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
T2 - An invited opinion paper
AU - Antal, Andrea
AU - Ganho-Ávila, Ana
AU - Assecondi, Sara
AU - Barbour, Tracy
AU - Bjekic, Jovana
AU - Blumberger, Daniel M
AU - Bolognini, Nadia
AU - Brunelin, Jerome
AU - Chanes, Lorena
AU - Dale, Matthew
AU - Dubbioso, Raffaele
AU - D'Urso, Giordano
AU - Filipcic, Igor
AU - Filipovic, Saša R
AU - Hirnstein, Marco
AU - Konings, Femke
AU - Langguth, Berthold
AU - Leocani, Letizia
AU - Sorkhabi, Majid Memarian
AU - Mulder, Marc
AU - Nikander, Mika
AU - Nowak, Rafal
AU - Oliviero, Antonio
AU - Onarheim, Balder
AU - O'Shea, Jacinta
AU - Pallanti, Stefano
AU - Rachid, Fady
AU - Rajão-Saraiva, Joana
AU - Rossi, Simone
AU - Sack, Alexander T.
AU - Sauvaget, Anne
AU - van der Scheer, Rik
AU - Schellhorn, Klaus
AU - Soria-Frisch, Aureli
AU - Szekely, David
AU - Tankisi, Hatice
AU - Cj Taylor, Paul
AU - Tendolkar, Indira
AU - Uusitalo, Susanne
AU - Baeken, Chris
PY - 2024/7
Y1 - 2024/7
N2 - 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.
AB - 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.
KW - Brain stimulation
KW - Medical device regulation
KW - Reclassification
U2 - 10.1016/j.clinph.2024.03.039
DO - 10.1016/j.clinph.2024.03.039
M3 - Article
SN - 1388-2457
VL - 163
SP - 280
EP - 291
JO - Clinical Neurophysiology
JF - Clinical Neurophysiology
ER -