Scoping review on regulation, implementation and postmarket surveillance of medical devices.

Abstract

Regulation and postmarket surveillance of medical devices have been criticized for being too lenient as compared to drug regulation and postmarket surveillance. Little is known about the factors that determine which medical devices are chosen for implementation among similar medical devices. Our aim was to systematically identify and characterize empirical studies on medical device regulation, implementation and postmarket surveillance, and to describe the recurring themes and trends in the stud