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https://hdl.handle.net/10316/115367
Título: | 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 | Autor: | Antal, Andrea Ganho-Ávila, Ana Assecondi, Sara Barbour, Traci Bjekić, Bjekić Blumberger, Daniel M. Bolognini, Nadia Brunelin, Jerome Chanes, Lorena Dale, Mathew Dubbioso, Raffaele D'Urso, Giordano Filipcic, Igor Filipović, Saša R. Hirnstein, Marco Konings, Femke Langguth, Berthold Leocani, Letizia Memarian Sorkhabi, Majid Mulder, Mark 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 Baeken, Chris |
Data: | Abr-2024 | Editora: | Elsevier | Projeto: | UID/PSI/01662/2013 | Título da revista, periódico, livro ou evento: | Clinical Neurophysiology | Resumo: | 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), including 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. | URI: | https://hdl.handle.net/10316/115367 | DOI: | https://doi.org/10.1016/j.clinph.2024.03.039 | Direitos: | embargoedAccess |
Aparece nas coleções: | FPCEUC - Artigos em Revistas Internacionais |
Ficheiros deste registo:
Ficheiro | Descrição | Tamanho | Formato | Entrar |
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Antal et al 2024_Final_Accepted_22_03_24.pdf | 674.42 kB | Adobe PDF | Acesso Embargado Pedir uma cópia |
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