Instructions for use medical devices

Instructions for use medical devices is the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.The documents regulating the conditions and rules of operation (for its intended purpose, maintenance, repair, storage and transportation), the values of the main parameters, characteristics (properties) of medical products guaranteed by the manufacturer, warranty obligations, as well as information about its disposal or destruction.

Refer to the order of Ministry of health of Russia No. 11n dated 19.01.2017 g. «On approval of requirements to the content of technical and operational documentation of the producer (manufacturer) of medical products» (Registered in Ministry of justice of Russia 10.03.2017 No. 45896). Adopted: March 14, 2017 (n 11n from 19.01.2017) requires that the manufacturer should develop instructions for the use of a medical device.

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