If you look closely at the above points, it becomes clear that a well executed and consistent review of current Scientific Literature (and Adverse Events) is a prerequisite. Without a means of discovering and compiling applicable new market information pertaining to your device it will be increasingly difficult to perform Post Market Surveillance at a high level year after year.
This is where a customized template and procedure can significantly increase your team’s efficiency for annual MDR filings. By implementing a Post Market Surveillance template you effectively standardize your submissions to the Notified Body. This not only makes creation/drafting of the reports more streamlined, but also increases the ease at which your Notified Body can review the reports.