Medical devices have historically been less regulated than their drug and biologic counterparts, both before and after coming to market. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety issues.
Furthermore, there is increased awareness that the nature of medical devices is rapidly changing as the market shifts from hardware-only devices to increasing numbers of hybrids of hardware and software, or even software as a medical device (SaMD).
New regulations in the EU and the experiences of the FDA in the United States suggest that medical device regulation overall faces some global challenges, including the correct balance between patient protection and avoiding stifling business and innovation, the changing nature of medical devices to become increasingly software-based, and the difficulties of post-market surveillance. This conference will explore how these concerns can be expressed and successfully addressed in a variety of countries, each with a different medical device market.