clinical evaluation

  The requirements for the periodic safety update report are defined in Article 86 of the EU MDR 2017/745. Specifically, the PSUR should include:   the conclusion of the risk-benefit analysis the main results of the post-marketing clinical follow-up Sales volume of the device and other characteristics of the population using it and, where possible, frequency of use of the device.   The PSUR must be prepared for each medical device or category of medical device and must include the results and conclusions of the post-market surveillance analyzes data collected as a result of the post-market surveillance plan together with a justification and description of any preventive actions and corrective measures undertaken.   Benefit-risk analysis   The benefit-risk analysis is part of the risk management process and must be performed throughout the life cycle of the medical device. The assessment of the risks and benefits of the device should

  The clinical evaluation of medical devices is undoubtedly one of the cornerstones of the new regulation. It is a very complex institution, the application of which requires an in-depth analysis of the regulation itself and which can help to dispel some doubts.   What is clinical evaluation? The clinical evaluation is a systematic and planned process aimed at continuously producing, collecting, analyzing, and evaluating clinical data relating to a device to verify its general safety and performance , including clinical benefits, when it is used as intended by the manufacturer.    It is therefore a business process that must be "systematic" and "programmed" and which aims to produce clinical data. The collection and analysis of such data serve to verify the safety and performance of the medical device.   What is clinical data? Clinical data is information relating to the safety and performance of the device. Such data can come from 4 sources”