Medical Device Post Market Surveillance Report Template

During the preparation of the medical device ce marking technical file the clinical evaluation report should be concluded with the help of post market surveillance pms procedure sop plan and report with its.

Medical device post market surveillance report template. While the psur is not new to the pharma world it is a fairly new concept to medical devices. Articles 82 through 86 and annex iii of the eu mdr outline the requirements for a post market surveillance system with. Medical device academy has created a post market surveillance plan template that you can download for free. If you are interested in learning more about pms and pmcf studies we also have a webinar on this topic. 5 the objective of this article is to describe the new eu regulation on pms of medical devices to compare it with our.

The new eu regulation aims to reinforce key elements of the existing regulatory approach including vigilance and market surveillance at the same time ensuring transparency and traceability to improve health and safety. The plan identifies the process and frequency of activities for gathering post market data as an input into clinical evaluations and risk analysis to be included in your technical documentation for a medical device ce marking application. View the medtech intelligence 2019 series of eu mdr ivdr conferences while companies currently must demonstrate a post market surveillance plan for ce marking the european union medical devices regulation 2017 745 increases requirements for post market surveillance pms. This would apply to class i devices for the mdr and to class a and b devices for the ivdr. Example post market surveillance report a post market surveillance report on a device manufacturer or device provides product liability insurance companies with the comprehensive adverse event metrics and trends they need to write better policies and reduce their risk.

We have developed high quality mandatory post market surveillance sop plan and report templates in line with en iso 13485 2016 section 8 2 1 and meddev nb med 2 12 rec 1 guideline. Post market surveillance report pmsr and periodic safety update report psur the implementation of the pms plan can lead to 2 different type of reports based on the class of the device. The first type is the post market surveillance report or pmsr. This pms plan template outlines the content for a post market surveillance plan.