Main findings of your Post Market Clinical Follow Up (PMCF).Conclusions of risk-benefit determination.The contents of this report are outlined in Article 86 of the MDR. Like the PMSR, the PSUR requires you to include a rationale and description of any corrective actions taken for product on the market. Additional information provides a summary of post market information, vigilance reporting, and current status of these devices on the market in the EU. It summarizes the results and conclusions from your PMS data. The PSUR is intended for moderate and high-risk devices (Class IIa, IIb, III, implantables).
The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices. This report becomes part of your Technical Documentation (the new moniker for the Medical Devices Directive Technical File) and is updated when necessary and made available to EU Competent Authorities upon request. It needs to summarize the results and conclusions of your Post Market Surveillance (PMS) data along with a rationale and description of any corrective actions taken for products on the market. The PMSR is intended for low risk Class I devices. The requirement to generate a Post Market Surveillance Report (PMSR) is outlined in Chapter VII, Article 85 of the EU Medical Device Regulation (MDR). What’s the difference between a PSUR and a PMSR? What’s the difference between a PSUR and a PMSR?.In this article we will address these common questions: Presentation: Periodic Safety Update Reports - Some commonly asked questions Author: Therapeutic Goods Administration Subject: risk management Keywords: presentation, tga, arcs, risk management plans, periodic, safety, update, reports Created Date: 9:34:17 PM. The US is alone in requiring two different types of reports, referred to as the NDA (New Drug Application) safety update (“quarter- ly”) and the annual (“periodic”) reports, both covering clinical experience however, the latter does not focus on detailed safety data. The PSUR can be an important source for the identification of new safety si. The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. It should be noted that PSUR and PMSR are new requirements under the completely revised post market surveillance activities defined by the MDR. While the PSUR is not new to the pharma world, it is a fairly new concept to medical devices. One of the curiosities of the new European Medical Device Regulation (MDR) EU 2017/745 is the requirement to prepare Medical Device Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR).