What does it mean when a product is clinically tested?

A clinical evaluation of a medical device is a process that aims to critically evaluate clinical data and demonstrate the safety and efficiency of the evaluated medical device subject in compliance with the intended purpose as defined by the manufacturer and under normal conditions of use.

A clinical trial means using the medical device on trial subjects within a process of systematic testing on the premises of a healthcare provider with the objective to:

  • demonstrate whether the tested medical device is suitable for use in accordance with the intended purpose, particularly from the standpoints of safety and effectiveness,
  • determine the impact of the tested medical device on the trial subject, and
  • specify side effects of the tested medical device and evaluate whether they represent an acceptable risk.

It is essential to distinguish between the opinion of a physician and a clinical evaluation.

A clinical evaluation of a medical device is a relatively demanding process in terms of both time and expense, which is governed by the applicable provisions of Act no. 268/2014 Coll. on medical devices.

The Ministry of Health even issued an instruction that defines a list of hospitals allowed to carry out clinical evaluations and at the same time also stipulates the minimum period of time during which the tested product must be monitored.


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