IMDRF Guide on Adverse Event Reporting Terminology: Overview
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
The new article describes the key terms and concepts used in adverse event reporting for medical devices.
The new article highlights the aspects related to the vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
The article describes in detail the approach to be applied with respect to clinical performance testing considerations including, inter alia, the ones associated with treatment parameters and protocols, safety and effectiveness endpoints and data, as well as adverse events