WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 4.3-EP: Show that every device conforms to the applicable essential principles of safety and performance throughout its life cycle, preferably by applying recognised international standards

What does 4.3-EP require?

Before placing a device of any class on the market, the manufacturer is responsible for ensuring and documenting that it satisfies every relevant IMDRF essential principle for safety and performance, and must be able to show the NRA that the device was designed and made to be safe and to work as intended over its life when used as the manufacturer intends. The general principles cover safe design and production for the intended user, performance as intended under specified conditions, supplying the safety and performance information users need, identifying and controlling known and foreseeable risks and weighing them against benefits, and protection against harm from transport, packaging and storage; additional principles apply to categories such as implants, powered devices, software, sterile devices and IVDs (with IVD-specific principles on performance characteristics and self-testing). The recommended route is to apply recognised international consensus standards, and the evidence, kept in the technical documentation, may be reviewed by the NRA before or after market entry.