Armenia Medical Device Post-Market Monitoring: EAEU Decision No. 174 Rules and Compliance

1. Key takeaways

Post-market surveillance at the Union level is uniformly governed by Decision No. 174 of the Board of the Eurasian Economic Commission dated 2015-12-22, which approved the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices; the underlying legal source is Article 8(2) of the Agreement signed on 2014-12-23 on unified principles and rules for the circulation of medical devices in the Eurasian Economic Union. The GRZAN conclusion: the three data sources defined by the monitoring rules determine the boundaries of manufacturer obligations — ① adverse event (incident) reports coming from users, manufacturers and state oversight; ② periodic safety and clinical effectiveness reports for Class 3 devices and implantable Class 2b/3 devices; ③ the manufacturer’s post-market phase data and corrective action system. A compliant post-market system must be structured around all three sources at once, because each source feeds a distinct obligation and each is examined during inspections.

2. Legal basis

3. Expert insights

Insight 1: Article 2 frames the purpose of surveillance as identification and prevention. This article provides that surveillance aims to ensure user safety, protect and promote public health, improve the quality of medical care, and to identify and prevent adverse effects and adverse reactions not stated in the instructions for use or the operating manual, adverse events (incidents), and the circulation of medical devices that do not meet the general safety and effectiveness requirements approved by the Eurasian Economic Commission. GRZAN note: this shows that surveillance covers adverse effects not stated in the instructions for use, and a manufacturer cannot confine its responsibility to what the documentation already states.

Insight 2: Article 3 defines surveillance as a four-step closed loop. The article provides that surveillance includes the collection, recording and analysis of adverse event (incident) information and the adoption of the relevant decisions. GRZAN note: the surveillance system must cover all four steps; collection alone does not constitute compliance, and the wording on adopting relevant decisions means that decision-making and disposition records must exist.

Insight 3: Article 4(a) lists three reporting sources. Surveillance is based on the analysis of adverse event (incident) reports at all stages of the circulation of medical devices in the Union; the reports come from: ① users of medical devices; ② manufacturers of medical devices; ③ authorized bodies of the member states when they exercise state oversight (control) over the circulation of medical devices. GRZAN note: with three sources, a manufacturer can be the reporting party or can be drawn into an investigation triggered by another party; post-market feedback channels oriented toward healthcare institutions and patients should therefore be established.

Insight 4: Article 4(b) sets the scope of periodic reporting. Surveillance is also based on the analysis of periodic safety and clinical effectiveness reports for Class 3 devices and for Class 2b and Class 3 devices implanted into the human body during the post-market phase, submitted by the manufacturer or its authorized representative. GRZAN note: the periodic reporting duty does not apply to all products, but to the specific scope of Class 3 plus implantable Class 2b/3 (see article 44 of this series).

Insight 5: Article 4(c) ties surveillance to the QMS. Surveillance is further based on the manufacturer’s system for collecting and analyzing safety and effectiveness data of medical devices in the post-market phase, and on corrective actions implemented under the quality management system requirements for medical devices approved by the Eurasian Economic Commission. GRZAN note: this provision links post-market surveillance with the QMS requirements of Decision No. 106 — surveillance is not an isolated activity but a component of the quality management system and is assessed during manufacturing inspections. Decision No. 106 also explicitly requires confirmation that the manufacturer has established a system for collecting and analyzing post-market safety and effectiveness data, keeps it current, and reports post-market surveillance results to the authorized body under the monitoring rules.

Insight 6: Armenian national law carries the surveillance function. Article 45 of the Law on Medical Care and Services for the Population provides that the powers of the authorized body include ensuring the collection and analysis of information on adverse events (incidents) arising during the use (operation) of medical devices and the adoption of the relevant decisions. GRZAN note: this is the domestic legal basis on which the Armenian competent authority performs the surveillance function; the reporting recipient for manufacturers in Armenia is the Ministry of Health system.

4. Practical recommendations

1. Build a four-step closed loop: establish a written collection, recording, analysis and decision procedure under Article 3 and retain decision records.
2. Open three feedback channels: set up adverse event feedback entry points for healthcare institutions, patients and distributors, and define internal routing deadlines.
3. Determine scope first: assess whether the product falls within Class 3 plus implantable Class 2b/3 and establish the periodic reporting duty accordingly.
4. Embed surveillance in the QMS: write the surveillance procedures into quality management system documentation so that they can be assessed during manufacturing inspections.
5. Clarify the reporting recipient: in Armenia the reporting recipient is the Ministry of Health system, and the authorized representative should define its role and deadlines in submission.

5. Verification checklist

1. □ Confirmed that the monitoring rules are Board Decision No. 174 and the legal source is Article 8(2) of the Agreement.
2. □ Established a written four-step closed loop procedure of collection, recording, analysis and decision.
3. □ Opened feedback channels for users and distributors with internal routing deadlines.
4. □ Determined whether the product falls within the periodic reporting scope of Class 3 plus implantable Class 2b/3.
5. □ Embedded the surveillance procedures in QMS documentation so they can be assessed during manufacturing inspections.
6. □ Clarified the reporting recipient in Armenia (Ministry of Health system) and the authorized representative’s submission duties.
7. □ Confirmed the competent authority’s information collection and analysis function under Article 45.

Regulatory information verified as of October 30, 2026.

About GRZAN: GRZAN supports medical device manufacturers entering Armenia and the Eurasian Economic Union with regulatory registration, quality management systems, post-market surveillance and import clearance compliance. For inquiries, contact info@grzanglobal.com.