Periodic Safety Update Reports (PSURs) are crucial reports, applicable to investigational medical devices, (i.e. devices without predicate) that manufacturers/importers of such medical devices need to submit to demonstrate how their products are performing after they have been sold. These reports are a key part of Post-Market Surveillance (PMS), a practice that monitors the safety and performance of investigational medical devices on the market.

A PSUR should have several parts that give a full picture of how a medical device is doing. Broadly, the MDR 2017 recommends that a PSUR to be structured as follows:

1. Introduction: Complete with the device details (intended use, mode of operation, etc.) , the reporting interval and description of the intended population.
2. Current worldwide marketing authorization status: Details of countries, where the device is approved, and/or countries where it is withdrawn with reasons thereof.
3. Action taken in reporting interval for safety reasons: Description of any significant safety actions during the reporting period.
4. Changes to reference safety Information: Any significant changes to reference safety information.
5. Estimated patient exposure: Estimates of size and nature of the population using the device, and detailed case histories of any problems people have had with it.
6. Presentation of individual case histories: Individual case information available to a license holder including brief case narrative, medical history indication, causality assessment etc.
7. Studies: Summaries of new safety findings that may affect device safety information.
8. Other Information: This should include details about the risk management plan.
9. Overall Safety Evaluation: Summary of the safety  concerns, benefit evaluation and Risk-benefit analysis along with the safety profile of the medical device.

The companies that manufacture/import the investigational medical devices are the ones who need to prepare and send these reports. It’s important they do a good job of making sure the reports are accurate and sent on time.

Here’s when and how to send these reports:

1. For the First Two Years: A report needs to be sent every six months.
2. For the Next Two Years: After that, a report is needed once a year.
3. Longer If Needed: Sometimes, more reports might be needed based on health needs.
4. All reports should now be sent online through the Sugam portal, which helps keep everything in order and easy to manage.

Periodic Safety Update Reports are more than just paperwork—they’re crucial for keeping investigational medical devices safe after they are sold. By carefully looking at safety information, companies and regulators can make decisions that keep everyone safe and ensure devices work as they should. This ongoing monitoring is key to keeping trust in medical technology high.

At Regulatory Solutions India (RSI), we specialize in providing regulatory consultancy services for medical devices If you need help navigating the submission process or ensuring compliance with the latest regulations, contact us.