The definition of a substandard medical device has been clarified

The definition of a substandard medical device has been clarified (such a device does not meet the safety and effectiveness requirements of medical devices, the requirements for their labeling, regulatory, technical and operational documentation and cannot be used safely for the purpose established by the manufacturer), and the concept of an “adverse event” has been introduced (this includes side effects not specified in the instruction / manual, adverse reactions when using medical devices, the interaction between medical devices, facts and circumstances of the adverse events, the identification of adverse events, and the necessity to report and report those adverse events to appropriate national authorities and health authorities). read more