TY  - JOUR
AU  - Antal, Andrea
AU  - Ganho-Ávila, Ana
AU  - Assecondi, Sara
AU  - Barbour, Tracy
AU  - Bjekić, 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  - Filipčić, Igor
AU  - Filipović, Saša
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  - Taylor, Paul CJ.
AU  - Tendolkar, Indira
AU  - Uusitalo, Susanne
AU  - Baeken, Chris
PY  - 2024
UR  - http://rimi.imi.bg.ac.rs/handle/123456789/1479
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.
PB  - Elsevier
T2  - Clinical Neurophysiology
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: An invited opinion paper
DO  - 10.1016/j.clinph.2024.03.039
ER  - 

@article{
author = "Antal, Andrea and Ganho-Ávila, Ana and Assecondi, Sara and Barbour, Tracy and Bjekić, 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 Filipčić, Igor and Filipović, Saša 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 Rajão-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 CJ. and Tendolkar, Indira and Uusitalo, Susanne and Baeken, Chris",
year = "2024",
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.",
publisher = "Elsevier",
journal = "Clinical Neurophysiology",
title = "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",
doi = "10.1016/j.clinph.2024.03.039"
}

Antal, A., Ganho-Ávila, A., Assecondi, S., Barbour, T., Bjekić, J., Blumberger, D. M., Bolognini, N., Brunelin, J., Chanes, L., Dale, M., Dubbioso, R., D'Urso, G., Filipčić, I., Filipović, S., Hirnstein, M., Konings, F., Langguth, B., Leocani, L., Sorkhabi, M. M., Mulder, M., Nikander, M., Nowak, R., Oliviero, A., Onarheim, B., O'Shea, J., Pallanti, S., Rachid, F., Rajão-Saraiva, J., Rossi, S., Sack, A. T., Sauvaget, A., van der Scheer, R., Schellhorn, K., Soria-Frisch, A., Szekely, D., Tankisi, H., Taylor, P. CJ., Tendolkar, I., Uusitalo, S.,& Baeken, C.. (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. in Clinical Neurophysiology
Elsevier..
https://doi.org/10.1016/j.clinph.2024.03.039

Antal A, Ganho-Ávila A, Assecondi S, Barbour T, Bjekić J, Blumberger DM, Bolognini N, Brunelin J, Chanes L, Dale M, Dubbioso R, D'Urso G, Filipčić I, Filipović S, Hirnstein M, Konings F, Langguth B, Leocani L, Sorkhabi MM, Mulder M, Nikander M, Nowak R, Oliviero A, Onarheim B, O'Shea J, Pallanti S, Rachid F, Rajão-Saraiva J, Rossi S, Sack AT, Sauvaget A, van der Scheer R, Schellhorn K, Soria-Frisch A, Szekely D, Tankisi H, Taylor PC, Tendolkar I, Uusitalo S, Baeken C. 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. in Clinical Neurophysiology. 2024;.
doi:10.1016/j.clinph.2024.03.039 .

Antal, Andrea, Ganho-Ávila, Ana, Assecondi, Sara, Barbour, Tracy, Bjekić, Jovana, Blumberger, Daniel M., Bolognini, Nadia, Brunelin, Jerome, Chanes, Lorena, Dale, Matthew, Dubbioso, Raffaele, D'Urso, Giordano, Filipčić, Igor, Filipović, Saša, Hirnstein, Marco, Konings, Femke, Langguth, Berthold, Leocani, Letizia, Sorkhabi, Majid Memarian, Mulder, Marc, Nikander, Mika, Nowak, Rafal, Oliviero, Antonio, Onarheim, Balder, O'Shea, Jacinta, Pallanti, Stefano, Rachid, Fady, Rajão-Saraiva, Joana, Rossi, Simone, Sack, Alexander T., Sauvaget, Anne, van der Scheer, Rik, Schellhorn, Klaus, Soria-Frisch, Aureli, Szekely, David, Tankisi, Hatice, Taylor, Paul CJ., Tendolkar, Indira, Uusitalo, Susanne, Baeken, Chris, "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" in Clinical Neurophysiology (2024),
https://doi.org/10.1016/j.clinph.2024.03.039 . .