An Overview of Recent Trends in Medical Device Pharmacovigilance Regulations

Device pharmacovigilance involves collection of all scientific information and data related to the assessment, processing and understanding of adverse events (AE) related to medical devices. It mainly involves the identification and evaluation of safety reports and signals. It also requires detection of any change in benefit-risk balance during its entire life cycle. With the increasing complexity of medications available, a comprehensive AE monitoring system is necessary to detect, evaluate & develop mechanism to prevent adverse events. Risk assessment should be done in initial stages of product development. Process needs to be conducted thoroughly & rigorously; however, it is impossible to detect all safety issues during clinical trials. Therefore, post-marketing surveillance which may be passive or stimulating has a significant role in assessing the actual safety aspects of medical devices.