The specifics for medical devices refer to a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This includes the type of medical conditions the device is designed to diagnose, treat, monitor, alleviate, or prevent.
Clinical evaluation of medical devices is one of the key steps for receiving the Conformité Européenne (CE), or the European Conformity certification in the European Union (EU) geography. The objective behind clinical evaluation of medical devices is to ensure patient/user safety, drive manufacturers and Notified Bodies (NBs) towards evidence-based decision-making, and at the same time inform them about Post-marketing Surveillance (PMS) activities.
As stated in the European Union Medical Devices Regulations (EU MDR) 2017/745, clinical investigation, is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” The entire purpose of clinical investigations is to demonstrate that medical devices are safe and effective when used for their intended purpose.
One may think that placing a medical device on the market is the final step; however, even after the device’s launch, the manufacturer is required to fulfill the Post-Market Surveillance (PMS) requirements. PMS involves activities to collect and evaluate the feedback/complaints related to the quality, performance, and safety of the devices, user surveys, technical and clinical watch, surveillance of competing devices throughout the device’s lifetime and take any corrective actions if necessary.
