Risk management is a continuous process covering the entire life cycle of a medical device and an in vitro diagnostic medical device.
Directive 93/42/EEC imposes a risk management obligation on the manufacturer. The international standard EN ISO 14971:2012, harmonised with the directive, sets out a process for the manufacturer to identify risks associated with medical devices, including in vitro diagnostic (IVD) devices, to evaluate and assess the associated risks, to control those risks and to monitor their effectiveness.
Risk analysis in the process of risk management allows to reduce the level of risk of hazards and their consequences. An in-depth risk analysis helps the manufacturer to develop principles of safety and use of the medical device.