Post-marketing for medical devices

Post-marketing for medical devices is the process that occurs after a medical device is placed on the market. It involves monitoring the safety and effectiveness of the device, updating the device’s instructions for use, conducting staff training on the use of the device, and reporting any issues that may arise during its use.

This process aims to ensure a high level of safety and effectiveness of medical devices during their use by patients and healthcare professionals. Leading medical device manufacturers often establish dedicated departments to handle post-marketing issues and interact with authorized representatives and regulatory bodies to ensure compliance with safety and effectiveness requirements.

The function of the authorized representative in this process is to promptly handle complaints and forward them to the manufacturer for review.