Should you file a PMS report or a PSUR? | Joe Hagan-Brown

Once a medical device has been legally placed onto the market, every manufacturer has a legal obligation to keep monitoring how their device is performing during actual use, and after they have released the product from their warehouse or production facilities.

These activities typically include receiving and reviewing complaints, gathering and interpreting feedback, conducting further clinical follow up, monitoring scientific literature, reporting serious incidents, identifying risks, and where necessary taking action to solve or present problems from occurring.

Collectively these activities are referred to as post-market surveillance.

The MDR requires that manufacturers periodically either document a Post market surveillance report, or a Periodic Summary Update Report. The contents of both of these technical documents are described in detail within the MDR articles 85 and 86.

These reports essentially collate the data which is gathered further to the prior planned PMS activities having been conducted. Its important that a manufacturer knows which document they are legally required to compile, and then also understand the frequency at which this need to be done. For certain device classes, additional actions are required by the manufacturer in terms of the sharing and making available of the report.

For our first blog post of 2024, we would like to share a one page guide to both the PMS report and PSUR. ELIB11 compares the contents of both and provides context as to the applicability of each. Its available at the link below and is also published in the free online MedRAS eLibrary.

Should you file a PMS report or a PSUR? If you’re a medical device manufacturer, find out which applies to you here, and know that you can contact MedRAS for further advice and guidance on how to implement an effective and MDR compliant PMS system.