How to Write a Periodic
Safety Update Report
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As a manufacturer of medical devices targeting the European Union (EU) market, you have to ensure that your devices comply with the EU Medical Device Regulation (EU) 2017/745 MDR). This regulation has established several important requirements that you have to fulfill if you wish to sell your devices in the EU.
One of these requirements is the periodic safety update report (PSUR), which must be updated and submitted periodically for approval by the Notified Body (NB). So, as you prepare to launch your new medical device into the EU market, make sure you understand how to write a periodic safety update report.
MDR requirements outline a specific format for writing a PSUR. It’s therefore important to make sure you are familiar with all the necessary elements of a PSUR before you start writing it. This article will help you understand the most important steps to write an excellent PSUR, capable of complying with MDR requirements.
What Is a Periodic Safety Update Report?
As outlined in Article 86 of MDR, a PSUR is a systematic review of the safety and effectiveness of a medical device that’s CE-marked and approved for the EU market. The EU MDR requires every manufacturer of medical devices that are sold in the EU to carry out surveillance of their devices, on an ongoing or continuous basis, to ensure that they remain safe and effective throughout their expected lifespans.
Failure to submit this report can lead to disapproval of your devices by the NB. But how often is a PSUR submitted? The PSUR should be submitted either annually (Class IIb and Class III) or at least every two years (Class IIa), depending on the classification of your medical device. For novel and high-risk medical devices, the PSUR should be submitted annually as part of the Technical Documents, outlined in Annex II and Annex III.
Before you start writing your PSUR, create a well thought-out plan for collecting the necessary data, putting it in the report, and submitting it. The post-market surveillance plan EU MDR aspect is important because it keeps you on the right track when compiling your report so that you don’t omit an important element of the report.
The PSUR is an important part of the post-market clinical follow-up (PMCF) report that you have to carry out periodically to ascertain the efficacy and safety of your medical devices. The PMCF study is a key requirement for selling medical devices in the EU that is clearly stipulated in the EU MDR.
But how is a PMCF study different from a clinical investigation? While the two activities share a similar objective–making sure the medical devices in the EU market are safe and effective for their intended purposes–the procedure for carrying them out is somewhat different. For instance, a PMCF study is performed on medical devices that already have a CE mark, while a clinical investigation is done on devices that are yet to be CE-marked.
Tips for Writing a PSUR
Although the EU MDR guidance has been helping medical device manufacturers to understand important aspects of the new regulations, some areas of the new regulation are still unclear. Still, there’s confusion around the sources of effectiveness and safety information you include in your PSUR.
When you’re compiling your PSUR, include data from various valuable sources, including clinical and non-clinical studies, spontaneous reports, product usage data, product utilization data, observational studies, and scientific literature. Follow the format outlined in guidelines such as MDCG 2022-21, the implementation of Regulation article 35 and Module VII of the guideline on good pharmacovigilance practices Module VII.
When you’re writing your PSUR, ensure that it meets the minimum data requirements described in the regulation, including data regarding the sale and usage of the device, device complaints, serious incidents reports, trend reports, field safety correction activities, relevant information from literature research, and corrective and preventive actions.
Always analyze your data before including it in your PSUR. Failure to do so will generate serious questions from the NB thus prolonging the process. A thorough analysis of the data will help you to identify trends and signals that might negatively affect the benefit-to-risk ratio of your device.
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You should create a well thought-out plan for your PSUR before you start writing it, and make sure the final report is properly aligned with the plan. Also, be sure to keep the goal of the report in mind and ensure the report fulfills it properly. Finally, following industry guidelines on best practices of the format and content required in the PSUR will ensure success.