The European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Regulation (EU IVDR) represent a complete overhaul of the EU regulations for medical devices and in-vitro diagnostic (IVD) devices.
One of the biggest changes in the new regulations is the addition of more rigorous postmarket surveillance (PMS) and vigilance requirements, which describe a more prominent role for medical device manufacturers once a device has made its way to market.
This article will focus on one aspect of these new PMS activities in particular: the Periodic Safety Update Report (PSUR). Keep reading to learn more about the PSUR, what it includes, and whether your device needs one.
The Periodic Safety Update Report is one of two new reports on postmarket surveillance that medical device manufacturers are required to maintain and submit to their Notified Body (NB) on a recurring basis.
The PSUR is a summary of the results of postmarket surveillance activities as well as the conclusions that manufacturers have drawn from those results. If the manufacturer has taken any corrective or preventive actions (CAPAs), a description and rationale for the actions must also be included in this report.
The Periodic Safety Update Report is part of a device’s technical documentation, and it has to be updated throughout the device’s lifecycle. The PSUR is initially submitted to a Notified Body during the device’s conformity assessment audit, but from then on it must be updated either annually or biennially.
For Class IIa medical devices the PSUR is a biennial requirement.
For Class IIb and III medical devices and Class C and D in-vitro diagnostics, the PSUR must be submitted annually.
The PSUR for Class III and implantable medical devices and Class D in-vitro diagnostics must be submitted via EUDAMED. This requirement can be found in Article 86(2) of MDR and Article 81(2) of IVDR. Both articles reference “an electronic system” that readers should take to mean EUDAMED.
Post Market Surveillance Report (PMSR)
The PMSR is very similar to the PSUR—it is also meant to summarize results and conclusions from your postmarket surveillance, and it also includes the rationale for, and description of, any CAPAs. However, there are some key differences:
The PMSR is required for Class I medical devices and IVDs in Class A and B. Essentially, the PSMR is for low-risk devices and the PSUR is for those with a moderate or high risk.
Your PMSR must be maintained and available to EU Competent Authorities upon request, but it does not need to be submitted on a regular basis. The MDR recommends updating your PMSR at least once every three years.
What do I need to include in my PSUR?
At minimum, your PSUR should include the following:
Your postmarket surveillance data
The conclusions of your benefit-risk analysis
A description of any CAPAs and the rationale behind them
The device’s sales volume and an estimate of the user population
The frequency of the device’s usage (if practical)
An analysis and summary of all the information listed above
This last point is important, because the PSUR is not about checking boxes. The Periodic Safety Update Report is intended to be an analysis of the postmarket data your company has actively collected. It’s a meaningful, regularly updated report that should help both regulators and internal stakeholders understand the safety and efficacy of your device during its time on the market.
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MDR and IVDR make it clear that postmarket surveillance and vigilance reporting should not be passive or reactive processes. It’s up to medical device manufacturers to consistently capture and analyze data on the performance of devices and ensure the results of that analysis are available to regulatory bodies.
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Sara Adams is a Medical Device Guru at Greenlight Guru and a Certified ISO 13485 Lead Auditor who began her career in the medical device industry in the post-manufacturing world. As an experienced Quality Engineer, she has been responsible for leading Corrective and Preventive Action (CAPA) investigations and...