Medical devices are an extremely important, versatile and complex product category within our global healthcare, ranging from e.g. wound care plasters to X-ray machines and present across all areas of our societies and daily lives. The structure of this industry is equally complex and comprises many different technologies, markets, big international and medium-sized and small manufacturers/suppliers, and numerous other stakeholders. Yet, compared to medicinal products, hospitals and medical staff, there is much less general awareness and understanding of the segment. In order to make these interrelationships visible, the book aims for the greatest possible simplification without leaving out important aspects. This introductory chapter views medical devices in the context of a “VUCA” world (volatility, uncertainty, complexity and ambiguity), determined by new technologies (such as software and artificial intelligence), increasing regulatory requirements (such as the MDR in Europe) and market changes. The focus is on Europe but in the context of other regions worldwide.