According to the Medical Device Regulation (MDR) post-market surveillance is mandatory for all medical devices regardless of classification and it can be defined as an action necessary by medical device manufacturers for proactive collection and review of experience gained from the devices placed on the market with an aim of monitoring the performance of medical devices. PMS activities are designed in a way that they generate data regarding the deice performance and enable preventive identification of problems that can potentially arise during usage and subsequently cause problems in patient monitoring or treatment. Over the years, PMS has mostly relied on medical device manufacturers and users for reporting adverse events involving MDs to relevant authorities in addition to performing regular servicing activities. However, this approach is limited by manufacturer bias. Hence, an effective method of post-market surveillance has been developed based on the metrological characteristics of medical devices. According to this method, post-market surveillance consists of three steps: visual inspection, electrical safety inspection and performance inspection.
Our Senior Research Associate, Prof. dr. Almir Badnjević will talk about this topic at the Fifth symposium of health technologies taking place on 29th of September.
