The In Vitro Diagnostics Regulation (IVDR) requires that the clinical evidence of an IVD be supported by scientific validity, analytical and clinical performance and that this evidence be recorded in the respective reports. How can this evidence be provided?
Scientific validity refers to the relationship of an analyte to a specific clinical or physiological condition.
The IVDR now requires scientific evidence even for devices that have already been marketed under the IVDD. Scientific literature on the analyte as well as expert reports and results from analytical and clinical performance studies are verified and documented in the report on scientific validity.
Analytical performance is the ability of a device to correctly detect or measure a particular analyte.
Analytical performance is generally verified by means of analytical performance studies and documented in the analytical performance report.
Clinical performance refers to the ability of a device to provide results that correlate with a specific clinical condition, a physiological or pathological process or condition in a specific target population and specific intended users.
Simply put: data from clinical performance studies, routine diagnostic tests and scientific literature are presented and evaluated in the clinical performance report. Clinical performance studies are unnecessary if sufficient clinical data are available from other sources, including scientific literature.
novineon CRO identifies the clinical evidence for your IVD through a systematic and structured review of scientific literature and documents it in the performance evaluation report.
Contact your novineon specialist.
Phone: +49 7071 98979 – 128