Transitioning to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746...
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As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as per the post-market surveillance plan.
Manufacturers of class IIa, class IIb and class III medical devices as well as class C and Class D IVD devices shall prepare a periodic safety update report (PSUR) by summarizing the results and conclusions of the analyses of the post-market surveillance (PMS) data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. PSUR shall be a part of technical documentation for all the categories mentioned above but not for custom made devices.
Throughout the lifetime of the device, that PSUR should update with following aspects:
We, Maven Profcon Services LLP. will take upon the Post-Market Surveillance activities upon request, including Periodic Safety Update Report and Post Market Surveillance Report!!!
Ans. Conclusions and results of Post market surveillance data which includes Complaint data, risk monitoring, vigilance, sales data; main findings of PMCF, conclusions of benefit risk determination, an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
Ans. PSUR update helps us in determining and analyzing the safety of the medical devices by identifying risks, evaluation benefit-risk ratio. It helps the manufacturer to implement necessary preventive actions.
