
Medical device technical file
The content of technical file (TF) for the purpose of state registration of a medical device (MD) in the territory of 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 the most part, the requirements of this order are similar to foreign ones, such as the requirements of the FDA (DMR, DHF, DHR), Directive 93/42/EEC, Directive 98/79/EC (in vitro), MDR (EU) 2017/745, IVDR (EU) 2017/746. But while the requirements are similar, they also have differences. The main difference is the provision and description of technical and functional characteristics and parameters of the device. All data must comply with the requirements of the standards in force exactly in the territory of the Russian Federation. Often we have to encounter the fact that in the Russian Federation there may be additional national standards for MD, regulating the requirements that do not exist abroad. Also, a new version of the standard adopted by the manufacturer may not yet be harmonized in the Russian Federation, or the version of the international standard may not be harmonized, but modified, that is, supplemented with requirements in relation to the international version of the standard. These circumstances are important to take into account at the stage of preparing a technical file for the Russian Federation in order to avoid unnecessary problems during testing and submission to Roszdravnadzor. The next important difference is the different interpretation of the same definitions, for example, " accessory of a medical device". In the Russian Federation (RF), the concept of "accessory" is interpreted in a stricter sense, for example, the accessory cannot be the device's power cable and many consumables, although it can be so abroad. This affects the provision of information in many sections of the technical file for the RF. Another difference in technical file is the scope of requirements for devices of different risk classes. While abroad there are fewer requirements for low risk class devices, this is not the case in the RF. In RF, the low risk class is not exempt from providing some information, the information can be withheld only if it is really not applicable for a particular deviсe. In conclusion it would be necessary to mention that without a properlyно prepared technical file it is impossible to start and successfully complete trials on the territory of the Russian Federation and to register the MD.