EAEU Classification Rules Decision No. 173 and Amendment No. 18

1. Key takeaways

Decision No. 173 of the Board of the Eurasian Economic Commission, adopted on December 22, 2015, approved the rules for classifying medical devices by potential application risk. It has been amended twice: by Decision No. 65 of May 23, 2023 and by Decision No. 18 of February 18, 2025. The focus of the 2025 amendment is to align the classification approach for software devices and in vitro diagnostic devices with IMDRF documents, while simultaneously repealing the standalone rules on distinguishing device components and combining multiple models into one registration certificate that had been set out in Decisions No. 116 and No. 123 of 2018. This means that after 2025, classification conclusions for software and IVD drawn under the older framework should not be carried forward unchanged.

The practical consequence is a re-verification obligation for portfolios with legacy classification decisions. A rule class or IVD risk class assigned before February 18, 2025 may no longer match the current text, and the difference can affect evidence requirements, expert review depth and market access timelines.

Classification is not an administrative label; it is the key that determines downstream obligations. The assigned rule class under Decision No. 173 drives the depth of technical documentation, the extent of testing, the configuration of clinical evidence and the intensity of post-market surveillance expectations. A one-class difference can therefore change the project budget and timeline substantially, which is why the 2025 amendment’s realignment of software and IVD categories matters operationally, not just doctrinally. Manufacturers should treat every re-verification exercise triggered by the amendment as an opportunity to confirm that the whole downstream package — evidence plan, labeling, surveillance setup — still corresponds to the class, rather than merely confirming the class letter itself.

2. Legal basis

The classification framework derives from the EAEU founding treaty, is implemented through Decision No. 173 as amended, and runs in parallel with Russian domestic classification for the national pathway. The table below lists the relevant instruments.

3. Expert insights

Insight one: the legal chain of the classification rules is clear. Decision No. 173 states in its preamble that it was adopted on the basis of Article 31 paragraph 2 of the 2014 Treaty on the Eurasian Economic Union, Article 4 paragraph 4 of the 2014 medical devices agreement, and Decision No. 109 of the Supreme Eurasian Economic Council dated December 23, 2014; its entry into force is tied to the entry into force of the agreement (30 calendar days after the agreement takes effect). Understanding this chain helps in judging whether room exists for later modification and in anticipating where future amendments would originate within the institutional structure.

Insight two: the 2025 amendment recentralizes multi-model combination into the main rules. Previously, the 2018 Decisions No. 116 and No. 123 separately governed the distinction of device components and the criteria for including multiple modified variants in the same registration certificate; Amendment No. 18 repealed them and folded the substance into Decision No. 173. Accordingly, any discussion today of combining multiple models into one registration certificate must apply the current text of Decision No. 173. Continuing to cite the repealed decisions in dossiers or internal procedures creates an easily detectable and entirely avoidable compliance defect.

Insight three: Russian domestic classification runs in parallel. The national pathway still determines type codes and classes under Order No. 4н. The two conclusions may differ: when a divergence appears, the rules corresponding to the filing pathway prevail, and the difference should be explained in the dossier. A written reconciliation table between the two classifications helps expert institutions understand the basis of the application and reduces clarification rounds during review.

The IMDRF alignment introduced by Amendment No. 18 also has a practical benefit worth noting: manufacturers holding IMDRF-based classification conclusions from other jurisdictions now have a closer conceptual bridge to the EAEU framework, which simplifies the justification of software and IVD classes in dossiers. The alignment does not make foreign conclusions automatically applicable — the current text of Decision No. 173 remains the governing instrument — but it reduces the argumentative distance between the two frameworks. In practice, a dossier that presents the classification rationale in the structure of the current EAEU rules, with references to the corresponding IMDRF concepts where appropriate, gives expert institutions a shorter path to agreement and reduces the likelihood of classification-related deficiency rounds.

4. Practical recommendations

1. Schedule a re-verification of every software and IVD classification conclusion made before February 18, 2025. Document the before-and-after comparison so that any resulting change in rule class or evidence scope can be traced and priced into the project plan.
2. Base new judgments on multi-model combination strategy on the current text of Decision No. 173, and stop citing Decisions No. 116 and 123. Update templates, SOPs and training materials so that the repealed references disappear from circulation.
3. Where classification conclusions differ between the national and Union pathways, explain the difference in the dossier in tabular form. Presenting the comparison clearly helps the expert institution follow the reasoning and shortens the review conversation.

5. Verification checklist

• □ The class of software products has been re-determined under the amended approach
• □ The classification conclusions for IVD products have been re-verified
• □ The multi-model combination strategy cites the current text of Decision No. 173
• □ Classification differences between the national and Union pathways have been explained in writing
• □ The entry-into-force status of Amendments No. 65 and No. 18 has been recorded

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Russian market with end-to-end regulatory services covering both registration pathways: national registration under ПП РФ No. 1684, including route selection among clauses 63, 87 and 101, and EAEU registration under ЕЭК Decision No. 46, together with classification strategy support under Decision No. 173 as amended. Our team helps define the optimal route for each registration unit, prepare dossiers and testing plans, coordinate with RZN and expert institutions, and track transition deadlines through December 31, 2027. For tailored support on Russia market entry, pathway selection and dossier preparation, contact GRZAN at info@grzanglobal.com.