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

Andrea Antal*, Ana Ganho-Ávila, Sara Assecondi, Tracy Barbour, Jovana Bjekic, Daniel M Blumberger, Nadia Bolognini, Jerome Brunelin, Lorena Chanes, Matthew Dale, Raffaele Dubbioso, Giordano D'Urso, Igor Filipcic, Saša R Filipovic, Marco Hirnstein, Femke Konings, Berthold Langguth, Letizia Leocani, Majid Memarian Sorkhabi, Marc MulderMika Nikander, Rafal Nowak, Antonio Oliviero, Balder Onarheim, Jacinta O'Shea, Stefano Pallanti, Fady Rachid, Joana Rajão-Saraiva, Simone Rossi, Alexander T. Sack, Anne Sauvaget, Rik van der Scheer, Klaus Schellhorn, Aureli Soria-Frisch, David Szekely, Hatice Tankisi, Paul Cj Taylor, Indira Tendolkar, Susanne Uusitalo, Chris Baeken

*Corresponding author for this work

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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.
Original languageEnglish
Pages (from-to)280-291
Number of pages12
JournalClinical Neurophysiology
Volume163
Early online date10 Apr 2024
DOIs
Publication statusPublished - Jul 2024

Keywords

  • Brain stimulation
  • Medical device regulation
  • Reclassification

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