What Are The Requirements For The Reagent Batch Used In Clinical Trials Of IVD Reagents?

After the type examination of the IVD reagents, the batch of the product used or not used in the type examination can be used for the clinical trials. There should be a clear statement in the report about the reagent lot number used in the clinical trial by each institution. If the clinical trial lasts a long time, or the number of reagents used for the clinical trial is large, more than one lot of the reagents may be needed to complete the clinical trial.

It should be noted that the products used for clinical trials, type examinations and analytical performance evaluations of IVD reagents should be produced under conditions that meet the requirements of the quality management system for medical device production, and the lot size should be sufficient.