Results for tag: "EU Vigilance System"

The EU Vigilance System market is a system of reporting and monitoring medical device safety in the European Union. It is designed to ensure that medical devices are safe and effective for use by patients and healthcare professionals. The system is managed by the European Commission and is based on the Medical Device Regulation (MDR). It requires manufacturers to report any incidents or problems with their medical devices to the European Commission. The Commission then assesses the reports and takes appropriate action. The system also requires manufacturers to provide information on the safety and performance of their medical devices. This includes information on clinical trials, post-market surveillance, and risk management. The system also requires manufacturers to provide information on the design, manufacture, and labeling of their medical devices. Companies in the EU Vigilance System market include Johnson & Johnson, Medtronic, Abbott, B. Braun, and Stryker. Show Less Read more