Trial design and approval

The performance evaluation plan involves identification of a set of tests and experiments on human subjects or with the use of biological material. Presenting reliable data regarding the efficacy of an in vitro diagnostic medical device constitutes the primary goal of the trial. When designing a trial, current regulatory requirements, ethical issues and a statistical analysis should be taken into consideration. A correct design of a trial facilitates its conduct by the investigational team.

Knowledge of legal regulations applicable for a given region allows to seamlessly complete the registration procedures, submit a trial to the Ethics Committee and obtain trial approval from relevant state authorities.


What legal requirements must be met in order to start a performance evaluation for a new diagnostic medical device?

A performance evaluation of a diagnostic medical device may be started after the manufacturer drafts the appropriate documentation and completes the device design stage. When the trial site location is established, all legal regulations related to starting a trial at the national level should be considered. It also needs to be established whether an application to the Ethics Committee is required.

How long does it take to obtain trial approval?

The time needed to obtain approval for conducting a performance evaluation depends on the trial type and trial site location. The approval process depends on dates of meetings of local Ethics Committees and deadlines of local state authorities.

What is an interventional clinical performance study?

In an interventional clinical performance study, test results obtained during the trial may influence patient treatment decisions and may be used to guide treatment.

What is risk assessment?

In a performance evaluation, “risk” means the combination of the probability of occurrence of harm and the severity of such harm. A risk analysis involves systematic use of available information to identify and estimate risks. Such activities include examination of various sequences of events which may cause dangerous situations and damage.

A risk analysis of an in vitro diagnostics device should result in defining all anticipated serious adverse device effects.

What is clinical performance study?

A clinical performance study is a clinical performance evaluation of a medical device. Its objective is to determine or confirm clinical performance of a device.