| Abstrakt: |
A recent study conducted at the University Medical Center Gottingen in Germany has highlighted the negative consequences of new European regulations on non-invasive brain stimulation devices. The introduction of the Medical Device Regulation (MDR) and the Annex XVI has caused confusion and problems in the field of brain stimulation. The researchers argue that overregulation is detrimental to research and future developments, and they call for a constructive dialogue to enact positive changes in the regulatory environment. This study emphasizes the need for attention and action from National Competent Authorities, ethical committees, politicians, and the scientific community to address these issues. [Extracted from the article] |
