ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device. ISO 14971 is a risk management standard for medical devices. Its purpose is to help manufacturers to establish a medical device risk management process that they can use to identify hazards, to estimate and evaluate risks, and to develop, implement, and monitor the effectiveness of risk control measures. International standard ISO 14971 - Medical devices - Application of risk management to medical devices was developed by the International Organization for Standardization (ISO) in 1998. It was written with participation from delegates representing 112 countries and has worldwide application to risk/benefit assessment. This standard is intended to provide manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with the use of medical devices.
The FDA and ISO 14971:2007 both acknowledge that the use of medical device technology entails some level of risk. The goal of risk management is to reduce product risk and to identify and understand the level of remaining risk and the impact that has on the users safety and the effectiveness of the product. EN ISO 14971:2012 became a European harmonized standard on August 30, 2012. The normative content is still in accordance with ISO 14791:2007. Compliance with harmonised European standards provides a “presumption of conformity” with the corresponding requirements of the associated Directive(s). Manufacturers can use harmonised standards to meet the ERs or other provisions of the Directives. However, the use of these standards remains voluntary. EN ISO 14971:2012 is a harmonised European standard currently supporting the following directives:
1. Medical Device Directive (MDD, 93/42/EEC as amended)
2. Active Implantable Medical Device Directive (AIMDD, 90/385/EEC as amended)
3. In Vitro Diagnostic Medical Devices Directive (98/79/EC as amended)