Please use this identifier to cite or link to this item:
https://hdl.handle.net/10316/115367
DC Field | Value | Language |
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dc.contributor.author | Antal, Andrea | - |
dc.contributor.author | Ganho-Ávila, Ana | - |
dc.contributor.author | Assecondi, Sara | - |
dc.contributor.author | Barbour, Traci | - |
dc.contributor.author | Bjekić, Bjekić | - |
dc.contributor.author | Blumberger, Daniel M. | - |
dc.contributor.author | Bolognini, Nadia | - |
dc.contributor.author | Brunelin, Jerome | - |
dc.contributor.author | Chanes, Lorena | - |
dc.contributor.author | Dale, Mathew | - |
dc.contributor.author | Dubbioso, Raffaele | - |
dc.contributor.author | D'Urso, Giordano | - |
dc.contributor.author | Filipcic, Igor | - |
dc.contributor.author | Filipović, Saša R. | - |
dc.contributor.author | Hirnstein, Marco | - |
dc.contributor.author | Konings, Femke | - |
dc.contributor.author | Langguth, Berthold | - |
dc.contributor.author | Leocani, Letizia | - |
dc.contributor.author | Memarian Sorkhabi, Majid | - |
dc.contributor.author | Mulder, Mark | - |
dc.contributor.author | Nikander, Mika | - |
dc.contributor.author | Nowak, Rafal | - |
dc.contributor.author | Oliviero, Antonio | - |
dc.contributor.author | Onarheim, Balder | - |
dc.contributor.author | O'Shea, Jacinta | - |
dc.contributor.author | Pallanti, Stefano | - |
dc.contributor.author | Rachid, Fady | - |
dc.contributor.author | Rajão-Saraiva, Joana | - |
dc.contributor.author | Rossi, Simone | - |
dc.contributor.author | Sack, Alexander T. | - |
dc.contributor.author | Sauvaget, Anne | - |
dc.contributor.author | van der Scheer, Rik | - |
dc.contributor.author | Schellhorn, Klaus | - |
dc.contributor.author | Soria-Frisch, Aureli | - |
dc.contributor.author | Szekely, David | - |
dc.contributor.author | Tankisi, Hatice | - |
dc.contributor.author | Taylor, Paul CJ. | - |
dc.contributor.author | Tendolkar, Indira | - |
dc.contributor.author | Baeken, Chris | - |
dc.date.accessioned | 2024-05-29T14:00:38Z | - |
dc.date.available | 2024-05-29T14:00:38Z | - |
dc.date.issued | 2024-04 | - |
dc.identifier.uri | https://hdl.handle.net/10316/115367 | - |
dc.description.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), 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. | pt |
dc.language.iso | eng | pt |
dc.publisher | Elsevier | pt |
dc.relation | UID/PSI/01662/2013 | pt |
dc.rights | embargoedAccess | pt |
dc.rights.uri | http://creativecommons.org/licenses/by-sa/4.0/ | pt |
dc.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 | pt |
dc.type | article | - |
degois.publication.title | Clinical Neurophysiology | pt |
dc.relation.publisherversion | https://www.sciencedirect.com/science/article/pii/S1388245724001184 | pt |
dc.peerreviewed | yes | pt |
dc.identifier.doi | https://doi.org/10.1016/j.clinph.2024.03.039 | pt |
dc.date.embargo | 2025-04-01 | * |
uc.date.periodoEmbargo | 365 | pt |
item.languageiso639-1 | en | - |
item.grantfulltext | embargo_20250401 | - |
item.fulltext | Com Texto completo | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.openairetype | article | - |
item.cerifentitytype | Publications | - |
Appears in Collections: | FPCEUC - Artigos em Revistas Internacionais |
Files in This Item:
File | Description | Size | Format | Login |
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Antal et al 2024_Final_Accepted_22_03_24.pdf | 674.42 kB | Adobe PDF | Embargo Access Request a copy |
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