Global Medical Device Post-Marketing Safety Reporting

With the ever-growing knowledge of science and application of advanced technology, new and sophisticated medical devices are being introduced in the market each year, for improved patient care. Simultaneously, with the use of these devices, there is also an increase in the number of unanticipated adverse events. The medical device vigilance is aimed at collection, detection, assessment, monitoring and prevention of adverse effects, which ultimately leads to protection of health and safety of patients, healthcare professionals, and other users. Most countries have incorporated a robust device vigilance framework to ensure that clear guidelines have been laid down based on safety and performance of the medical device. The manufacturer must also ensure that all the mandatory reporting requirements set by the respective regulatory agencies are met wherever the device is undergoing clinical trials or being marketed.

This article briefly summarises global medical device reporting requirements with specific focus on the European Union (including Northern Ireland), Great Britain, the United States of America, Japan and Canada.