ABSTRACT
It is widely accepted that ‘safety’, i.e. ‘freedom from unacceptable risk’,1
alone is not a sufficient criterion for the legal marketing of medical devices; the devices must be capable of operating in some way that contributes to the diagnosis, therapy or support of the patient. This additional feature is certainly a key factor in the regulation of medical devices. It is described in different ways, but is often referred to as ‘effectiveness’, ‘efficacy’ or ‘performance’. This Chapter examines the differences between these concepts and how devices are determined to satisfy the requirements, and proposes a model for future legislation.
