Periodic Safety Update Reports: Another document to manage for medical device manufacturers…
The European Union Medical Device Regulation (EU MDR) came into effect in May of 2021, and was like an earthquake to the medical device industry. The implementation of this regulation shook the foundations of establishing product safety and compliance, forcing companies to rebuild their infrastructure on evaluating medical devices to withstand the new stringent guidelines. A critical component of the EU MDR is the Periodic Safety Update Reports (PSURs), which is a document that manufacturing companies of medical devices create and submits at defined intervals by device classification. A PSUR is mandatory for Class III, IIb, and IIa devices. Class I devices do not require a PSUR and instead a post market surveillance report (PMSRs). The frequency of submission intervals for PSURs is defined by device classification and risk, for Class III and IIb devices updates need to be made at least annually while for Class IIa updates are required to be made at least every two years.
PSUR documents must include:
Summary of the Device with Post-Market Data: The quantity of devices sold, the countries that it is marketed in, along with the population using the device.
Analysis of Post-Market Data: Any collected data related to the device’s safety and performance, such as complaints, reportable incidents, field actions, and any corrective/preventative actions taken.
Volume of Sales and Estimate Usage: Estimation of the size and characteristics of population that use the device along with volume of sales.
Benefit-Risk Determination: Evaluation of available safety and performance data of the device to provide a benefit-risk analysis towards using the device.
Main Findings from Post-Market Clinical Follow-Up (PMCF): Where applicable, a summary of main findings from PMCF activities is to be provided.
Medical device manufacturers are now challenged to manage another document that involves cross-functional departments to collaborate and output a PSUR. Manufacturers already were struggling to remediate quality systems towards the EU MDR and existing required documentation, with the PSUR addition meeting submission deadlines became another obstacle.
Best practices that can facilitate a smooth transition towards managing PSURs include:
Engage with cross-functional teams, and fully define each team’s role and content they would be responsible for to avoid any conflict or confusion when generating the PSUR.
Streamline the process and create a template that is consistent, and where applicable requiring minimal changes aside from device specific data.
Utilize programs for data management that can easily output the necessary information in the same format for all PSURs.
The PSUR documents will eventually be uploaded to EUDAMED once available for public access. With the PSUR requirement by EU MDR being very new, there is not yet a clear definition as to what is expected from medical device manufacturers through this document. As multiple companies go through submissions and reviews, notified bodies, and the EU governing bodies may provide further guidance and expectations after seeing companies’ different interpretations of the PSUR. Further, once these documents become available to the public, the intended audience of the new requirement, based on feedback from readers changes may emerge for these PSUR documents. The PSUR document mandated by EU MDR focuses on a risk-based approach to evaluating medical devices to ensure they remain safe and effective for use in patients. It provides an evidence-based conclusion that gives patients transparency while demonstrating accountability of the medical device manufacturers with the primary goal being patient safety.
Medical device manufacturers must remain proactive and diligent in their compliance and risk management processes to adhere to the EU MDR guidelines and reach out for professional advice/consulting as necessary.
For additional guidance on the content of PSURs, here are some beneficial resources:
