Introduction: Borderline medical devices are products in a 'gray area,' this means due to their characteristics, they could belong to different 'legal products.' In addition, regulation is a controversial topic and may change depending on the country which may put public health at risk and distort the market.
Areas covered: This article analyzes how borderline medical devices are managed in the American and the European legislation. We compared the decisions made by both regulations on the devices of the Manual on Borderline and Classification Medical Devices of the European Commission for the first three sections, those which deal exclusively with medical devices.
Expert opinion: 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 a priori 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.
Keywords: Border; European Commission; FDA; manual; medical devices.
Borderline products do not have a simple product classification and can be managed differently depending on different countries. The different classification between countries has economic consequences for companies and patients. In this article, the American and European regulations system is compared, specifically borderline products, using as a tool the Borderline and Classification Manual of the European Commission. Results show the international consensus is necessary to avoid barriers to trade and contribute to innovation. Although both regulations have points of improvement, with the data from the Manual (EU), it seems that American regulatory system could be more efficient, although copying some of its strengths could be complicated due to the intrinsic characteristics of the European system. However, studies with quantitative data are needed to corroborate this statement.