Abstract

In this article, I identify the peculiar challenges of current regulation in the UK to assess the safety of new medical devices. Not only is there a limited role for the regulatory authority in assessing their safety, but also no clinical investigation might be needed before many new devices can be marketed for use in populations across the European Union. As a lay member of a committee flagged to review research involving medical devices, I describe some of the difficulties we face in this regard as well as recent developments designed to raise regulatory standards.