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Authorized representative — any legal person or sole proprietor who is a resident of Ukraine or is registered in accordance to the Ukrainian legislation, or a representative office of a foreign business entity, that is duly authorized by the manufacturer to act on his behalf with regard to the obligations of the manufacturer under its Technical Regulation.

Placing on the market — launching of medical device, except clinical investigation or performance evaluation of its specifications, with a view to distribution and/or intended use on the Ukrainian market, regardless of whether it is new or fully refurbished.

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

A medical device for in-vitro diagnostics, means any medical device, particularly 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;
  • a congenital abnormality;
  • to determine the safety and compatibility with potential recipients;
  • to monitor therapeutic measures.

Specimen receptacles are those devices, whether they are a vacuum-type or not, specifically intended by their manufacturers 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 — any medical device relying for its functioning on a source of electricity or any source of power other than that directly generated by the human body or gravity.

Active implantable devices — any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain inside of the body after the completion of the procedure