Hi - For IVD products meant for clinical trials in EU, the correct labelling statement is - For IVD Performance Evaluation Only and/or with Test tube with a question mark symbol. And these studies will be registered/notified to the corresponding National Competent Authorities according to the National/Local laws.
Whereas, if the products are meant for validation to be performed at inter company site in EU, not for clinical trials, then what is the labelling statement that we need to use on the products?
Is it okay if we use the same, "for IVD performance evaluation only" wit the corresponding symbol?
Thanks,
Sreenu
Whereas, if the products are meant for validation to be performed at inter company site in EU, not for clinical trials, then what is the labelling statement that we need to use on the products?
Is it okay if we use the same, "for IVD performance evaluation only" wit the corresponding symbol?
Thanks,
Sreenu