American and European legislation on border medical devices.

Borderline medical devices do not have to be understood as something specific to each country. The different classification of products creates international borders. It is necessary to create working groups in international organizations in which global consensus is reached. Although it seems that the American system could be more efficient, studies with quantitative data from authorized devices are needed to show that. Until EUDAMED is not fully operational and open access, it will not be possible to develop them.