This report examines examples of new and emerging governance models that aim to support the responsible development of diagnostics and treatments based on the latest advances in biomedicine. In particular, it presents programmes and initiatives that aim to manage uncertainty in the development and approval of new medical products and thereby to improve the understanding of the risk/benefit balance. It also identifies some of the main challenges for policy makers, regulators and other communities involved in the translation of biomedical innovation and health technologies from the laboratory bench to point of care.