Risk Classes 1, 2a, 2b and 3 for Medical Devices in Russia

1. Key takeaways

The Russian potential risk application class (klass potentsialnogo riska primeneniya) has four levels: 1, 2a, 2b, and 3. The class is not a labeling nicety; it determines three concrete things. First, it decides whether the testing scope includes toxicological studies and human clinical trials. Second, it decides whether a manufacturing site inspection is required within the state registration procedure. Third, it sets the tier of the state fee for expert review. In short, the class is the main input to both the timeline and the budget of a Russian registration project, and an error at this stage propagates through every later step.

Under the national pathway, the class is determined according to the catalogue of Order No. 4n of the Ministry of Health. Under the union pathway, it is judged according to EEC Decision No. 173. The two systems correspond at the level of classes, but the details of determination differ, and the same product can legitimately receive different treatment in each framework. Manufacturers operating in both systems should treat classification as a dual exercise, performed twice with two legal references, rather than assuming that one analysis serves both routes.

2. Legal basis

3. Expert insights

Insight 1: The class is an input to the cost function. The expert review fee is tiered by class. The current practical estimate is 72,000 rubles for class 1, 104,000 rubles for class 2a, 136,000 rubles for class 2b, and 184,000 rubles for class 3. If the same device is assigned different classes in the two databases, the consequence is not only a difference in fees but also a difference in the testing program: a higher class may pull toxicological studies or clinical trials into scope that a lower class would not require. Budget models should therefore treat the class as a variable to be verified in both frameworks, not as a single fixed assumption copied from another market.

Insight 2: Contact time and invasiveness are the core variables. The union classification rules use non-invasive devices, invasive devices of short-term, transient, or long-term duration, and implantable devices as the main axis, with the contact site serving as an escalation trigger, for example the central circulatory system or the central nervous system. Active implantable devices intended to come into direct contact with the heart, the central circulatory system, or the central nervous system fall into class 3. The dwell threshold in the definition of an implantable device is 30 days or more. Reading these rules against the actual anatomy of use, rather than against generic product descriptions, is what produces defensible classifications.

Insight 3: The 2025 amendment changed the determination approach for software and IVD. EEC Amendment Decision No. 18 (February 18, 2025) aligns the treatment of software-based devices and in vitro diagnostic devices with the approaches of the IMDRF documents, and repeals the separate rules on distinguishing device elements and merging multiple models contained in Decision No. 116 of 2018 and Decision No. 123 of 2018. This means that the class of the same software product under the new approach may differ from the previous judgment. Legacy classification conclusions should not be carried forward without review.

4. Practical recommendations

1. Support every classification conclusion with a written argument: list each determination basis for the product, including contact site, duration, invasiveness, implantability, and whether the device is active, rather than merely citing the catalogue result.
2. When the same product is placed in both Russia and the EAEU, perform the determination twice, once under Order No. 4n and once under Decision No. 173, and compare the outcomes explicitly in the project record.
3. Re-verify the class of software and IVD products after the 2025 amendment; conclusions issued under the previous approach should not be reused without a documented review.
4. Recalculate the expert review fee tier against the confirmed class at project start and again before filing, so that budget assumptions match the amounts actually charged.

5. Verification checklist

• □ The type code and recommended class have been obtained from the catalogue of Order No. 4n
• □ A cross-determination has been completed under Decision No. 173 (including Amendment No. 18)
• □ The four determination bases of contact site, duration, invasiveness, and active status have been documented in writing
• □ The expert review fee tier has been estimated from the class and the amounts re-checked against the current schedule
• □ The class conclusions for software and IVD products have been re-verified after the 2025 amendment

GRZAN provides risk classification services for the Russian and EAEU frameworks, including written classification arguments aligned with Order No. 4n and EEC Decision No. 173, dual-framework comparison for products placed in both systems, and fee and testing scope planning based on the confirmed class. Our classification records are structured for reuse in later amendments and union conversion projects, saving clients repeated analysis work. For classification and registration support in Russia, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.