 The European Union has not yet implemented a regulatory framework for medical devices similar to the one for pharmaceuticals, despite the fact that there is a need for such a framework due to the limited availability of treatments for rare diseases. A survey conducted by the European Commission showed that the majority of respondents were in favour of an often medical device directive which would provide incentives for companies to develop new medical devices for rare diseases. However, the United States already has a humanitarian use device exemption which provides some relief for patients suffering from rare diseases. Without a regulatory framework in place, post-market surveillance and quality of life data collection are essential for ensuring patient safety and monitoring the effectiveness of these devices. This article was authored by Mark M. Dooms.