Armenia EAEU Circulation Mark EAC: Rules and Usage under Decision No. 26

1. Key takeaways

The special circulation mark is the outward-facing declaration applied once registration is complete; its design, meaning, permitted users and timing are all governed by Board Decision No. 26 dated 2016-02-12. The GRZAN conclusion is that the EAC mark may only be affixed by the manufacturer or its authorised representative, and only before the device is placed into circulation on the union market; affixing it without union registration constitutes false marking. The abbreviation EAC stands for Eurasian Conformity.

2. Legal basis

3. Expert insights

Insight one: Article 2 writes the meaning of the mark as a double confirmation. The article provides that the special circulation mark indicates that the medical device bearing it has passed the registration procedure established within the union and confirms conformity with the general requirements for medical device safety and effectiveness and with the requirements for the implementation and maintenance of the medical device quality management system. The GRZAN observation is that this clause ties the EAC mark to two instruments at once: Decision No. 27 on general requirements and Decision No. 106 on quality management system requirements. The mark therefore signifies not only that a device has been registered but, implicitly, that the quality system behind it has been assessed.

Insight two: the design carries a mandatory technical description. Under the description of the mark approved by Decision No. 26, the mark is a square outline with the abbreviation EAC placed inside, centred along the vertical axis of symmetry; the abbreviation is formed from three stylised Latin letters E, A and C drawn with right-angled graphics of equal height and width, repeated to the exact proportions of the square on a light or contrasting background. The square outline is broken at the bottom, and the abbreviation MED — corresponding to medical — is embedded in the break. The mark must be monochrome and contrast with the colour of the surface to which it is applied, and the line width of the EAC elements equals the line width of the square outline. The GRZAN observation is that the MED lettering is what distinguishes the medical device mark from other EAC uses; it must not be dropped when the printing plate is prepared.

Insight three: Article 4 grants the affixing right to two parties only. The article provides that affixing of the special circulation mark on a medical device is carried out by the manufacturer of the device or its authorised representative. The GRZAN observation is that, combined with the elevated status of the authorised representative introduced by Decision No. 43 of 2026, foreign manufacturers should state the affixing authorisation separately in the power of attorney, defining its scope by model and batch and allocating responsibility explicitly.

Insight four: Article 5 pins the timing to before placement into circulation. The article provides that the special circulation mark must be affixed before the medical device is placed into circulation on the territory of the union. The GRZAN observation is that this is a strict sequence — mark first, release second. In practice it means the mark must be applied, or printed on the packaging, during production; it cannot be added after the goods have arrived in Armenia.

Insight five: the mark, the registration certificate and the import certificate are three separate credentials. The registration certificate is issued by the competent authority of the reference state and, after coordination with the recognition state, covers the relevant member states. The import conformity certificate is a one-time entry permit specific to Armenia. The EAC mark is a product-level circulation identifier. The GRZAN observation is that none of the three substitutes for another; the frequent error of affixing EAC on the strength of an import certificate alone constitutes improper use where union registration has not been obtained.

4. Practical recommendations

1. Install a pre-affixing gate: add a front-end check in the release workflow confirming that the union registration certificate has been issued; no affixing before it.
2. Prepare artwork strictly to the official description: verify the four elements — square outline, EAC abbreviation, MED lettering in the bottom break, and monochrome contrast.
3. State the affixing right separately in the power of attorney: record the EAC authorisation, the model range it covers and the division of responsibility in the document appointing the Armenian authorised representative.
4. Affix during production: move the marking step into the production or packaging stage so nothing needs to be added after arrival at the border.
5. Track the three credentials in separate ledgers: record the status of the registration certificate, the import certificate and EAC affixing as independent line items in the compliance register.

5. Verification checklist

1. □ Confirmed that EAC stands for Eurasian Conformity under Board Decision No. 26.
2. □ The mark has been checked against the four elements of the official description: square outline, EAC abbreviation, MED lettering, monochrome contrast.
3. □ The EAC affixing authorisation is stated separately in the power of attorney.
4. □ A pre-affixing gate confirming issuance of the union registration certificate is built into the release workflow.
5. □ The affixing step has been moved into the production or packaging stage.
6. □ The compliance register records the registration certificate, import certificate and EAC affixing status separately.
7. □ The verification requirements for circulation marking of registered devices in Armenian sales channels have been confirmed under Decision No. 26.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with EAC marking strategy for the Armenian market, from artwork verification against the official description to authorisation drafting and compliance ledger design. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.