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-Reference-Cited by-同舟云学术

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

Published:2024-07 Issue: Volume:163 Page:280-291
ISSN:1388-2457
Container-title:Clinical Neurophysiology
language:en
Short-container-title:Clinical Neurophysiology

Author:

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

Publisher

Elsevier BV

Reference13 articles.

1. Low intensity transcranial electric stimulation: safety, ethical, legal regulatory and application guidelines;Antal;Clin Neurophysiol,2017

2. European reclassification of non-invasive brain stimulation as class III medical devices: a call to action;Baeken;Brain Stimul,2023

3. Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk;Bikson;Brain Stimul,2018

4. Limited output transcranial electrical stimulation 2023 (LOTES-2023): updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk;Bikson;Brain Stimul,2023

5. Unforeseen side-effects of the novel regulation of non-medical brain stimulation devices in the European Union;Bublitz;Brain Stimul,2023

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. European medical device regulation: Perfection is achieved, not when there is nothing more to add, but when there is nothing left to take away;Clinical Neurophysiology;2024-07