Glossary

Authorized representative means any legal or natural person-entrepreneur, a resident of Ukraine or registered according to the law of Ukraine, representative of the foreign business that is appropriately empowered by the manufacturer to realize legal acts on his behalf concerning manufacturer’s obligations, stipulated by Technical regulations.

Placing on the market means the first making available a medical devices intended for clinical investigations or performance evaluation on the Ukrainian market with a view to distribution and/or intended use regardless of whether this medical device is new or fully refurbished.

Medical device  means any instrument, apparatus, machine, appliance, software, material or other product, intended by the manufacturer to be used, alone or in combination (including software, intended by the manufacturer to be used for diagnostic and/or other medical purposes and is necessary for proper operation of medical device), for diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation or compensation for an injury or disability, investigation, replacement, modification, or support of the anatomy or of a physiological process, control of conception and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

In vitro diagnostic medical device means any medical device which is a reagent, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  concerning a physiological or pathological state,
  concerning a congenital abnormality,
  to determine the safety and compatibility with potential recipients, 
  to monitor therapeutic measures.

Specimen  receptacles are  those  devices, whether vacuum-type or not, specifically intended by their manufacturer  for  the  primary  containment  and  preservation  of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; 

Active medical device is any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

Active implantable medical device (hereinafter – device) – active medical device, intended for full or partial introduction to the patient’s body surgically or by other medical means or through natural orifice, that should remain in the body after finishing of the introduction procedure.