Introduction: Favoring innovation by making timely medical technology available to people and by securing patients' safety is a challenge.
Areas covered: The new European Medical Device Regulation (MDR) will have a central implication in the development of new devices and could affect their innovation and availability, as well as discourage investment in research within Europe.
Expert opinion: Start-ups and small companies might not be able to cope with the increasing complexity and the required changes of perspective. Health-care institutions are facing an increasing availability of complex technologies, while data on their clinical efficacy and cost-effectiveness are rarely provided. A partnership/collaboration between health-care institutions, academia, and private industries will enhance their own specific interests with the common goal of improving overall health and quality of life. The complexity of the subject combined with the variety of specialists and stakeholders involved requires the implementation, in hospital centers of clinical excellence, of units dedicated to the whole path of the medical device innovation. Stakeholders should quickly provide adequate measures to facilitate the complex medical device innovation path under the more stringent MDR aimed to increase safety and quality of care.
Keywords: MDR 2017/745; Medical Device Regulation; Medical device; Value based healthcare; clinical investigation; clinical trial; cost-effectiveness; effectiveness; engineering; innovation; regulatory; safety; statistics; surveillance.