EU
The new article provides an in-depth overview of the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
Saudi Arabia
The new article describes in detail the regulatory approach to be followed concerning the manufacturing process, post-market surveillance, and other aspects.
IMDRF
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
IMDRF
The new article describes the key terms and concepts used in adverse event reporting for medical devices.
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
