For many medtech companies, structured, post-market surveillance reporting requirements are a new component of a product’s regulatory lifecycle. The EU MDR/IVDR regulations introduced a host of new post-market surveillance requirements for medical devices and in vitro diagnostics made available for sale in the EU—including regular summary reporting to be recorded within the device technical file or submitted directly to Notified Bodies. This article provides a brief background of Periodic Safety Update Reports (PSUR), the types of products which they’re applicable to, and what content is typically included in a PSUR.
The Periodic Safety Update Report or PSUR is not a new term, at least to the pharmaceutical community. The industry has been operating with regulations related to PSUR for some time. But for the medical device and IVD community, it’s a new requirement that stems from EU Regulations MDR 2017/745 (article 86) and IVDR 2017/746 (article 82). A PSUR is basically a report summarizing critical actions and conclusions derived from post-market surveillance data of a medical or in vitro diagnostic device. 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 introduction of the PSUR under the MDR and IVDR requires a more consistent, standardized, and systematic review of all Post Market Surveillance (PMS) data by medical and IVD device manufacturers. The PSUR is meant to summarize the results and conclusions of the analysis of the post-market surveillance data that has been gathered, resulting from the activities detailed in either the Post-Market Surveillance Plan (PMSP). In addition, any rationale and description of any preventive and corrective actions taken for safety reasons should be included.
The PSUR is for specific classes of medical and IVD devices, as per the table below:
Note: a European competent authority or Notified Body can request your PMSR or PSUR at any given time.
The purpose of a PSUR is for manufacturers to demonstrate with objective evidence that they have designed and deployed a Post-Market Surveillance system which uses data to drive action within their Quality Management System and ensure the continued safety, performance, and efficacy of their devices. It’s intended for moderate and high-risk devices (MD Class IIa, IIb, III: IVD Class C and D) and provides a detailed summary of results and conclusions derived from the PMS data.
Medical device and IVD manufacturers need to prepare a PSUR for each device, and where relevant, for each category or group of devices. The manufacturer is responsible for preparing and updating the PSURs and making it part of the technical documentation that should be included with the Essential Principles/GSPR’s. These reports must be clear, organized, searchable and in easy-to-read format.
The PSUR should be a stand-alone document. While the content of a PSUR can vary, depending on the amount of specific data the vendor chooses to include, the PSUR should, at a minimum, always include: an executive summary, safety conclusions and benefit-risk determination, main findings of the Post Market Clinical Follow-up (PMCF) [or Post Market Performance Follow-up for IVDs], vigilance data, information about sales volume, user population, and usage frequency. A PSUR is meant to provide an overview of information, not to be a complete duplicate of all the PMS report information.
Something very important to note, A PSUR is required throughout the lifetime of the device plus the shelf-life where relevant. So for example, A single use device could have a lifetime of 1 year, but a shelf life of 5 years. After the end of device production, the PSUR can be stopped only when the cumulative data of the PSUR issued for this device covers the duration of the shelf life (6 years).
The PSUR format is composed of two elements: the PSUR form and the PSUR report.
The PSUR report is a PDF file that the manufacturer will be required to upload in EUDAMED for class III devices and for implantable devices. The PSUR form is an electronic form that will be completed by the manufacturer in EUDAMED, after they have finished the “completeness” check.
The PSUR form contains all your relevant administrative information as well as data to identify and distinguish between different PSURs for the same device. It should also contain data necessary for the registration of the PSUR in EUDAMED. The PSUR form will be available by the Commission on their website at a later date to be announced.
The PSUR report will contain all of the core content including the executive summary, grouping of devices, sales volume, and PMS data discussed in the previous section.
PSUR requirements, and PMR data are now a critical part of the technical documentation that regulatory affairs professionals in medtech are required to maintain. Along with the expanded GSPR requirements that come with the MDR/IVDR rollouts, traditional approaches to managing technical docs are no longer effective, and can be prohibitively time-consuming to maintain. Regulatory Intelligence Management (RIM) systems, like Rimsys, can provide a much more powerful, effective, and streamlined way to manage all of a products’ technical files and supporting documentation.
To learn more about RIM systems, read our case study to see how a global leader in in vitro diagnostics was able to reduce the time spent on maintaining technical docs by 99% or request a custom demo of the Rimsys platform.