MDCG Guidance on Safety Reporting in IVD Performance Studies: Reporting Form
The new article provides comprehensive guidance on the reporting form to be used in the context of performance studies involving in vitro diagnostic medical devices.
The new article provides comprehensive guidance on the reporting form to be used in the context of performance studies involving in vitro diagnostic medical devices.
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
The new article provides an in-depth overview of the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
The new article describes in detail the regulatory approach to be followed concerning the manufacturing process, post-market surveillance, and other aspects.
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.