Performance studies of in vitro diagnostic medical devices
Information
Type
Miscellaneous
Regulated products
IVDMD, Medical Devices
Topics
Clinical Investigations And Performance Studies
Description
Decision tree performance studies IVDR / MPDG
Request for authorisation
Notification of a Post-Market Performance Study in accordance with Article 70(1) of Regulation (EU) 2017/746 (IVDR)Notification of a Post-Market Performance Study
Notifications of performance studies involving companion diagnostics using only left-over samplesNotifications of performance studies involving CDx
Substantial modifications
SAE reporting for performance studies
Temporary Halt, Early Termination or End of a Performance Study
Tags
Organization
Country / Region
Germany
License
Other (Public Domain)