Medical Device

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A device, instrument, software, etc., that, according to the manufacturer’s intended use, is employed for:

diagnosing or treating a disease;
maintaining anatomy or physiological processes (in case of injury or disability);
controlling fertility.

To achieve its purpose, it may use medicinal substances, immunological and metabolic agents, which enhance the desired effect of the medical device (i.e., the medicinal substance alone does not achieve the goal).

Medical devices are classified into 4 classes: I, IIa, IIb, and III, where class I indicates the lowest risk and class III indicates the highest risk. For registration of class I devices, it is sufficient to be included in the Register of persons responsible for placing medical devices, active implantable medical devices, and in vitro diagnostic medical devices on the market. For all other classes, involvement of a notified body and obtaining a certificate of conformity is required.

Medical Device

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Medical Device

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