Every device discussed in this book exists within a regulatory framework that determines whether it can be sold, in which countries, and under what conditions. This is not a topic that most readers will find inherently exciting. But it is one that directly affects whether the right devices reach the people who need them, and understanding it has become increasingly important.
Part V consists of a single chapter because the regulatory landscape, while complex, is a unified subject. Chapter 19 explains why medical devices are regulated, how the regulatory systems work in Europe, the United Kingdom, and the United States, and what the safety standards behind those systems actually require. It addresses the cost question of why a medical-grade stimulator costs thousands rather than £50, and the growing problem of manufacturer withdrawals, where the cost of regulatory compliance is driving specialist devices off the market.