Periodic Safety Update Report (PSUR) for Medical Devices Overview
Periodic Safety Update Report (PSUR) are not only important for medicinal products but also for medical devices. It is a report summarizing critical actions and conclusions derived from post-market surveillance data of a medical or in vitro diagnostic device (IVD). All associated preventive and corrective actions should be documented throughout the lifetime of the device, even if the product is no longer on the market.
The primary objective of a Periodic Safety Update Report (PSUR) for medical device is to enable manufacturers to substantiate, using verifiable evidence, the effective implementation of a Post-Market Surveillance (PMS) system. This system should utilize data to initiate proactive measures within their Quality Management System (QMS), thereby ensuring the ongoing safety, performance, and effectiveness of their medical devices. The PSUR is applicable to moderate and high-risk devices, such as Medical Device Class IIa, IIb, III, and In Vitro Diagnostic Classes C and D. It serves as a comprehensive compilation of outcomes and deductions drawn from the Post-Market Surveillance data.
The PSUR format consists of two components: the PSUR form and the PSUR report. Manufacturers are obligated to upload the PSUR report (in PDF format) for class III and implantable devices on EUDAMED. Subsequently, they will complete the PSUR form as an electronic submission in EUDAMED, following the "completeness" check.
The PSUR form includes essential administrative details and data to differentiate between various PSURs for a specific device. It will also incorporate information required for registering the PSUR in EUDAMED. The Commission will make the PSUR form available on their website at a later, yet-to-be-announced date.
When it comes to navigating the nitty-gritty of Post-Market Surveillance (PMS) and ensuring compliance with the latest medical device regulations, partnering with Freyr for the exceptional PSUR requirements proves to be a game-changer.
With over a decade of experience in the field, dedication to quality, and commitment to delivering clear, organized, and easy-to-read PSUR reports, medical device and IVD manufacturers can confidently demonstrate the safety, PSUR report template, performance, and efficacy of their products. Freyr’s comprehensive PSUR solutions allows companies to focus on innovation and patient well-being while leaving the regulatory intricacies in capable hands. With Freyr as your trusted PSUR partner, rest assured that your medical devices will continue to thrive in the market and, most importantly, serve the needs of patients worldwide.
- Development of PMS strategy for the device based on risk profile.
- Identifying the requirements of the EU MDR Post Market Surveillance, IVDR Post Market Surveillance,ISO 13485-2016, 21CFR, and guidance documents to enable effective implementation of a post-market surveillance system.
- Evaluating existing PMS data for ensuring target country-specific compliance.
- Ensure vigilance reports are completed on time and in compliance with local requirements.
- Development of user manuals/quick start guides, post-market customer feedback (surveys).
- Regulatory support for the review and compilation of the annual reports, and Post Marketing Surveillance (PMS) reports.
- Leverage PMS data to support compliance with the new regulations.
- Plan and implement the post-market clinical follow-up activities.
- Support for product recall, complaint handling, and Medical Device reporting, as per country-specific regulations.
- Assured compliance with recent applicable regulations.
- Literature Search
- Finalization of the literature search string
- Sales documentation and graphical representation of the device sales and usage data
- Trend Analysis
- Complaints, feedback, deviations, Field Corrective Actions data analysis and conclusions
- MAUDE and MEDWATCH and other country specific databases search and summary of public adverse events
- Summary of Clinical/Performance Evaluation Report (CER/PER) findings
- Analysis of PMCF data findings
- Modification of pre-defined text based on the findings
- Templatization of Periodic Safety Update Report (PSUR)
- Overall document review and compilation of Periodic Safety Update Report (PSUR)