European Legislation on Medical Devices Revision

摘要

In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its consequences. Medical devices and the in vitro diagnostic devices are estimated to comprise more than 500,000 products. These devices play a crucial rule in the diagnosis, prevention, monitoring and treatment of diseases and the safety of the blood used in transfusion.