英国标准协会BSI：2024年医疗设备和体外诊断设备的符号和信息要求白皮书（英文版）

The information supplied with the device is a fundamental requirement for the safe use of a medical/in vitro diagnostic device. The instructions for use (IFU) are crucial as they inform the user of a device's intended purpose and of its proper use, as well as any precautions to be taken. Being aimed at ensuring that the devices are used in a safe and effective way, it is vital that the information provided is adequate for the device itself. The label is defined in the Regulations as the w