EAEU Decision No. 46: Registration and Expert Review Rules Explained

1. Key takeaways

Decision No. 46 of the Eurasian Economic Commission, adopted on February 12, 2016, approved the rules for the registration and expert review of medical devices for safety, quality and effectiveness. It is the operational master document of the Union pathway. Reading it requires attention to three blocks: the composition of the registration dossier and the submitting party, the organization of expert review (including the reference state and recognizing states), and the handling of changes and cancellation after certification. Registration certificates obtained under Union rules are without term, which is a key difference from some member states’ historical systems.

The absence of an expiry date should not be mistaken for the absence of ongoing obligations. The certificate endures, but the manufacturer remains bound by change procedures, renewal of supporting data where required, and full post-market surveillance duties. Compliance is verified against the unified register entry rather than against a paper document, so the register record must be kept accurate throughout the device lifecycle.

The identity of the submitting party is a further structural point that first-time applicants often overlook. Under Decision No. 46, the application is made through a representative established in the member state concerned, which means the quality of that representative’s engagement with the authority and expert institutions directly affects the review experience. The applicant retains responsibility for the accuracy of the dossier, but the procedural interface — form submission, deficiency correspondence, register data — runs through the local party. Selecting that party for competence rather than convenience, and defining the division of responsibilities in writing, removes a common source of missed deadlines and unanswered authority requests during the review window.

2. Legal basis

Decision No. 46 operates within a framework of companion decisions, each governing one layer of requirements. The table below lists the acts that together define the Union registration system.

3. Expert insights

Insight one: Decision No. 46 and its companion decisions stand in a skeleton-and-muscle relationship. Decision No. 46 governs procedure; Decision No. 27 governs general requirements, labeling and operating documentation; Decision No. 173 governs classification; Decision No. 174 governs post-market surveillance. Omitting any one of these blocks makes it impossible to assemble a usable dossier, and this is precisely where many first-time applicants underestimate the workload. A complete gap analysis against all four companion instruments should precede any dossier drafting, so that evidence generation can be scoped realistically.

Insight two: registration and expert review form one continuous step. Under Union rules, the registration procedure is no longer split into separate, independent confirmation stages of first verifying the technical side and then verifying the clinical side; instead it is completed within a single continuous procedure. This determines that, at submission, test data and technical documentation must be essentially complete. There is no structural opportunity to file a partial dossier and complete it later, so the internal readiness gate before submission must be strict.

Insight three: an open-ended certificate is conditional. The certificate carries no expiry date, but this does not relieve the holder of obligations for changes, updates and post-market surveillance; the relevant requirements are implemented through the interface between member-state levels and Union rules. What remains continuously verifiable is always the register record, not the paper certificate held by the registrant. Manufacturers should therefore treat register-data accuracy and change-filing discipline as core compliance activities, equal in weight to the initial submission itself.

Because the procedure is continuous, deficiency handling also takes on a particular character: expert comments arrive against the dossier as a whole, and responses must reconcile testing, technical documentation and labeling at the same time. Manufacturers who prepare a cross-reference matrix between dossier sections, test reports and labeling claims before submission find deficiency responses dramatically easier, because each comment can be traced to the underlying evidence and answered precisely. The same matrix later serves change management, since any modification of design or labeling can be checked against the original evidence chain before the change procedure is initiated under the rules of Decision No. 46.

4. Practical recommendations

1. Run a self-check using synchronized comparison tables across the skeleton-and-muscle group of documents, not only Decision No. 46. Build one table per decision, map each requirement to a dossier section, and review the mappings whenever any of the decisions is amended.
2. Before submission, conduct a completeness and consistency review: the dossier, test reports and labeling and operating documentation must correspond to one another without contradiction. Inconsistencies between a test report scope and the claimed device variants are a recurring source of deficiency letters and avoidable delays.
3. Immediately after certification, establish the post-market plan aligned with Decision No. 174 requirements, rather than carrying over the home-country system. Adapt vigilance forms, reporting timelines and competent-authority contacts to the Union framework, and train the responsible personnel on the new procedures before the first commercial shipment.

5. Verification checklist

• □ The dossier list and submission method have been checked against Decision No. 46
• □ The general requirements of Decision No. 27 have been addressed point by point in the technical documentation
• □ The classification conclusion has been re-verified per Decision No. 173 (including Amendment No. 18)
• □ The post-market plan has been prepared per Decision No. 174
• □ Post-certification change procedures have been registered in the internal system

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.