The new regulation of non-medical neurotechnologies in the European Union: overview and reflection

The regulation of neurotechnologies for non-medical purposes such as enhancement, gaming, or well-being is a topic of ongoing controversy. Without much attention, the European Union addressed it by two implementing regulations to the Medical Device Regulation (MDR) for non-invasive brain stimulation devices, passed in December 2022. This paper presents main aspect of these regulations and the conditions for placing non-medical neurodevices on the EU market, especially the risk threshold and the requirement for pre-market certification. It also provides a first critical comment on selected aspects and the unclear situation regarding research only devices which has alarmed the European neurotechnology sector.