Module 16 2022

9/2/2022

PSUR embedded in the PMS and CER

The PSURs should capture the results and conclusions of the analyses of the PMS data gathered by the PMS Plan + the following: a) the conclusions of the benefit-risk determination; b) the main findings of the PMCF; and c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device. In other words, there needs to be a close connection between the PMS process and the CER and Risk Management review process to process this data in a reliable and chronological manner. And in the case of Class III devices and implantable devices this needs to be uploaded to EUDAMED as well…

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PSUR embedded in the PMS and CER • Inputs for PSUR are to be mentioned in the PMS Plan (article 84), further specified in Annex III MDR. The PMS Plan shall address the following: o information concerning serious incidents, including information from PSURs, and field safety corrective actions; o records referring to non-serious incidents and data on any undesirable side-effects; o information from trend reporting; o relevant specialist or technical literature, databases and/or registers; o information, including feedbacks and complaints, provided by users, distributors and importers; and o publicly available information about similar medical devices.

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© NAMSA 2021

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