
Instruction for user for medical devices
The content of the User Manual (UM) as well as Instruction for user (IFU) of medical devices (MD) for the state registration of a medical device in the Russian Federation is regulated by the Order of the Ministry of Health of the Russian Federation dated 19 January 2017. N 11n "On Approval of Requirements for the Content of Technical file and User Manual of the Manufacturer of a Medical Device (Order 11n). For disposable medical devices UM is the Instructions for Use, and for reusable MD is the Operating Manual. User manual for the Russian Federation must be written in Russian, a multi-language version is allowed. As for the requirements to the content and methods of providing UM for MD, in Russia these requirements are stricter in relation to the foreign regulations. Firstly, the UM for Russia must contain not only data that can be called "relevant" for the user, such as intended use, indications, contraindications, precautions, instructions for use and maintenance, etc., but also information on all technical characteristics (including package sizes), drawings /schemes of MD, information on all materials of manufacture regardless of the type and risk class of the device. All this information must be identical to the technical file on the MD submitted to Roszdravnadzor. This circumstance makes the UM for Russia more extensive and informative in relation to the original instructions of a foreign manufacturer. Secondly, the requirements for information contained in the User Manual, as well as in the technical file, are the same for all classes depending on the potential risk of MD, that is, the list of necessary information for MDs, for example, class 1 and class 3 is identical, but the applicability of the requirements depends on the type of MD. Thirdly, Order 11n regulates that the UM for MD of class 1 and class 2a of potential risk class may be provided to the user in a reduced form, on the condition that the amount of information provided is sufficient for the intended use of the medical device and such use is safe. In abroad, by exception, instructions for use are not required for class I and class IIa devices if these devices can be used safely without any instructions. In case of delivery of the device with abbreviated instructions to Roszdravnadzor, it is still necessary to submit both the full UM, where it is prescribed to provide the abbreviated version to the user, and the abbreviated UM for approval and verification of sufficiency of its content. It is important to note that after issuing a registration certificate for an MD, a scan copy of the UM will be published on the website of Roszdravnadzor in the section "State Register of Medical Devices and Organisations (Individual Entrepreneurs) that manufacture medical devices"[1]. Please note that the manufacturer must supply devices with an UM that is identical in content to the UM published on the Roszdravnadzor website; this is critically important from the point of view of medical device turnover. In conclusion, it would be important to say that without properly prepared both Technical file and User Manual , it is impossible to start and successfully complete trials in the territory of the Russian Federation and to register MD.