
Check-in classification in EAEU
The rules for registering medical devices (hereinafter referred to as MD) in the territory of the Eurasian Economic Union (hereinafter referred to as the EAEU) are regulated by the order of the Board of the Eurasian Economic Commission dated September 21, 2021, No. 148 "On the draft decision of the Council of the Eurasian Economic Commission 'On amendments to the Rules for registration and examination of safety, quality, and efficacy of medical devices' (hereinafter referred to as order No. 148).
Regarding the classification of MD, there are some differences from the classification within the national registration system when registering within the EAEU. For example, in the EAEU, there is such a concept as the field of application of MD (this concept does not exist in the national system). The field of application of MD is determined according to the decision of the Board of the Eurasian Economic Commission dated April 16, 2019, No. 62 "On the classifier of medical application areas of medical devices." This classifier assigns a code to each registered MD depending on the area of medical use, for example, if MD is used in obstetrics and gynecology, it will correspond to code 0200300.
To determine the class of potential risk of using MD in the EAEU, there is also a separate regulatory document – the decision of the Board of the Eurasian Economic Commission dated December 22, 2015, No. 173 "On the approval of the Rules for the classification of medical devices depending on the potential risk of use." It is worth noting that when determining the risk class of MD within the EAEU, the same criteria are considered as within the national system.
Another difference in the classification of MD is the definition of the type code – if during registration in the territory of the Russian Federation, the selection of the appropriate type code of MD is carried out through the service "Nomenclature classification of medical devices by types" on the official website of Roszdravnadzor, then during registration in the territory of the EAEU, the section of normative-reference information "Nomenclature of medical devices of the Eurasian Economic Union" on the official website of the portal of common information resources and open data of the EAEU is used. The rules for maintaining this EAEU nomenclature are regulated by the decision of the Board of the Eurasian Economic Commission dated December 29, 2015, No. 177 "On the Rules for maintaining the nomenclature of medical devices." Although many type codes in the EAEU coincide with the codes in the national system, the number of type codes is different – there are 1.5 times more type codes in the national system nomenclature than in the EAEU system nomenclature.
It is also worth noting that for MD registered in the EAEU, the OKPD 2 code is not specified, as this is the All-Russian Classifier of Products by Economic Activities and it does not apply to other states that are part of the EAEU.
If we talk about specifying the assortment and composition of MD, then in the EAEU the concept of "model (brand) of MD" is used instead of the concept of "variant," which is used in the national system. According to order No. 148, the model (brand) of MD is a variant of the MD characterized by specific design-technological solutions and specific values of its target (functional) purpose indicators. Moreover, when indicating the number of MDs supplied in one package, in the EAEU, only a specific number of devices can be used. It is not allowed to indicate a range and use the wording "no more than ... pcs." In the case that the number of devices in the package can vary depending on customer demand, for example, the package may contain either 1 pc., 5 pcs., or 10 pcs., then when registering in the EAEU, this should be indicated as 3 separate models with the same name and different quantities of devices in the composition.