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
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2024
Authors
Antal, AndreaGanho-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
CJ. Taylor, Paul
Tendolkar, Indira
Uusitalo, Susanne
Baeken, Chris
Article (Published version)
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Show full item recordAbstract
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, therefor...e 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.
Keywords:
Medical device regulation / Brain stimulation / ReclassificationSource:
Clinical Neurophysiology, 2024Publisher:
- Elsevier
Funding / projects:
- AA is supported by the DFG (AN 687/9-1, VIRON), EU-Horizon 2020 (PAINLESS, 101057367). AGA is supported by the Portuguese Foundation for Science and Technology (FCT) Grants 2020.02059.CEECIND (https://doi.org/10.54499/2020.02059.CEECIND/CP1609/CT0015). The Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC) of the Faculty of Psychology and Educational Sciences of the University of Coimbra is supported by the Portuguese Foundation for Science and Technology and the Portuguese Ministry of Education and Science through national funds and co financed by FEDER through COMPETE2020 under the PT2020 Partnership Agreement [UID/PSI/01662/2013]. BL got research funding from the Tinnitus Research Initiative, Bayhost, the German Research Foundation, the German Bundesministerium für Bildung und Forschung, the American Tinnitus Association, AstraZeneca, cerbomed, Neuromod and the European Union’s Horizon 2020 research and innovation programme, funding for equipment from MagVenture and Deymed Diagnostic; travel and accommodation payments from Eli Lilly, Lundbeck, Servier, and Pfizer; royalties from Springer and he owns shares of Sea Pharma. DMB receives research support from CIHR, NIH, Brain Canada and the Temerty Family through the CAMH Foundation and the Campbell Family Research Institute. He received research support and in-kind equipment support for an investigator-initiated study from Brainsway Ltd. He was the site principal investigator for three sponsor-initiated studies for Brainsway Ltd. He also received in kind equipment support from Magventure for two investigator initiated studies. He received medication supplies for an investigator-initiated trial from Indivior. He is a scientific advisor for Sooma Medical. He is the Co-Chair of the Clinical Standards Committee of the Clinical TMS Society (unpaid). LC is supported by the Ministry of Science and Innovation of Spain (PID2020-119677RB-I00), the Government of Catalonia (2021SGR01010) and the Catalan Institution for Research and Advanced Studies (ICREA Acadèmia).
- Ministry of Science, Technological Development and Innovation of the Republic of Serbia, institutional funding - 200015 (University of Belgrade, Institute for Medical Research) (RS-MESTD-inst-2020-200015)
- TWINNIBS - Twinning for excellence in non-invasive brain stimulation in Western Balkans (EU-HE-CSA-101059369)
- SU is supported by the University of Oulu and the Research Council of Finland Profi 7 352788.
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Institut za medicinska istraživanjaTY - 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 - CJ. Taylor, Paul 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 CJ. Taylor, Paul 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., CJ. Taylor, P., 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, CJ. Taylor P, 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, CJ. Taylor, Paul, 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 . .