Place of High-risk Medical Devices in European Recommendations with a Focus on End-users

Abstract

As shown by recent incidents and scandals related to the use of high-risk medical devices an adapted regulation throughout the European Union is important. The European directives and the regulation issued by the member states include recommendations which apply to high-risk medical devices. The present study aims at collecting the recommendations regarding high-risk medical devices and specific to each country. Legislation, guidelines, scientific publications and grey literature have been searched. Different trends seem to appear in the states with the most advanced legislation: an increase of controlled trials, a better traceability, development of specialized registries, an improved vigilance system and an increased involvement of endusers. Although poorly present in the legislation, the end-users are more and more integrated to the development process of medical devices. Ergonomics and user experience can be seen as key factors of a successful medical device. Several important issues are stressed regarding the training and information of healthcare practitioners for implantation of the medical device and its initial setting if required. New avenues have also to be envisioned such as context of use analysis and user-centred design.