EU regulations for brain stimulation devices

Two changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) in May, 2021 and the Annex XVI in December 2022, 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.



If you would like to know more about the regulatory aspects of brain stimulation and to be updated our  efforts, please read our opinion paper:


with an editorial comment: