EAEU Medical Device Legal Tree for Armenia 2026: Treaty, Agreement and EEC Decisions

1. Key takeaways

The EAEU regulatory framework for medical devices is a four-layer tree: the Treaty on the Eurasian Economic Union, then the Agreement of December 23, 2014, then the Council decisions and Board decisions of the Eurasian Economic Commission, and finally the Union nomenclature and technical documentation. The GRZAN practical conclusion: Council decisions govern the substantive rules of registration and conformity assessment, while Board decisions govern procedural rules such as classification, nomenclature and vigilance. The two bodies are different rule-makers, and citations must state explicitly whether a decision is Council Decision No. X or Board Decision No. X; mixing the two makes the provision impossible to locate and invites challenges from reviewers who read the citation literally.

2. Legal basis

3. Expert insights

Insight 1: Decision No. 109 is the commissioning document for the whole family of implementing rules. Supreme Eurasian Economic Council Decision No. 109 of 2014-12-23, on the implementation of the Agreement on the Common Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union, is the common citation basis for nearly all subsequent decisions. GRZAN has verified the preamble paragraphs of Council Decisions No. 26, 27, 28, 29, 38 and 42: each states that it was adopted in pursuance of Decision No. 109. This chain shows that the implementing decisions are homologous, and that amendments tend to move in coordinated groups.

Insight 2: the division between the Council and the Board can be read from the cited provisions. Council decisions (No. 26, 27, 28, 29, 42, 46 and 106) cite Article 31(2) of the Treaty together with specific articles of the Agreement; Board decisions (No. 173, 174 and 177) likewise cite Article 31(2) of the Treaty but pair it with the specific items of Annex 2 to the Rules of Procedure. GRZAN notes that this difference corresponds to the different internal levels at which the two categories of matters are assigned within the Union; in practice there is no need to debate which carries higher force, but the name of the adopting body must never be swapped in a citation.

Insight 3: entry-into-force clauses come in three formulations, which fix the starting point for Armenia. GRZAN has mapped three patterns: first, 30 calendar days after the entry into force of the Agreement (Board Decisions No. 173 and 174); second, 10 calendar days after the entry into force of the Protocol on the Accession of Armenia (2015-12-02), and in no case earlier than 10 calendar days after official publication (Council Decisions No. 26, 27, 28, 42 and 46); third, 180 calendar days after official publication (Council Decision No. 144 of 2021) or 30 calendar days after official publication (Board Decision No. 46 of 2018). The second pattern is the time anchor specific to Armenia and is the key to determining when any given decision became applicable there.

Insight 4: the nomenclature documents form the fourth layer. Board Decision No. 177 of 2015-12-29 approved the Rules for Maintaining the Nomenclature of Medical Devices, and Board Decision No. 46 of 2018-04-03 approved the Nomenclature of Medical Devices of the Eurasian Economic Union (NMI). The nomenclature is the coding target that a submission must hit, harmonized with GMDN. It is a technical rather than a normative document, but the use of NMI codes in the Union common process is mandatory, so code maintenance cannot be left to the end of the project.

4. Practical recommendations

1. Build a regulatory tree ledger: maintain an internal ledger across the five layers of treaty, agreement, Council decisions, Board decisions and nomenclature, recording for each entry the reference number, publication date, entry-into-force date and current amendment status.
2. Cite the adopting body in full: in external documents always write Council Decision No. 46 of the Eurasian Economic Commission of February 12, 2016, and never abbreviate it in ways that confuse it with European Union acts.
3. Watch for group amendments: amendments tend to arrive in coordinated groups (for example Decision No. 25 of 2022-03-17 amended Decision No. 28 and Decision No. 26 amended Decision No. 38), so a single amendment event requires several ledger updates.
4. Maintain the nomenclature separately: keep NMI codes as an independent field and re-verify them whenever product models change.

5. Verification checklist

1. □ A five-layer regulatory tree ledger has been established with current amendment status recorded.
2. □ Council decisions and Board decisions have been distinguished, and the adopting body is named correctly in citations.
3. □ The entry-into-force anchor of each cited decision for Armenia has been checked against the three formulations.
4. □ The commissioning position of Decision No. 109 in the regulatory chain of this product has been confirmed.
5. □ An NMI code has been assigned to the product and the matching basis has been recorded.
6. □ The 180-calendar-day entry-into-force clause of Decision No. 144 of 2021 has been checked.
7. □ It has been confirmed that none of the cited decisions has been invalidated by a later decision (for example No. 116 and No. 123).

Regulatory information verified as of October 30, 2026.

GRZAN services. GRZAN International maintains regulatory tree ledgers, citation reviews and NMI code management for EAEU market access programs. For inquiries, contact info@grzanglobal.com.