Armenia Medical Device Recalls: Corrective Actions and Field Safety Actions under EAEU Rules

1. Key takeaways

Union rules distinguish between corrective action and field safety corrective action for medical devices: the former targets the cause of an identified nonconformity or adverse event, while the latter targets the risk of death or serious deterioration in health. The GRZAN conclusion: the trigger criterion for a field safety corrective action is the severity of the risk consequence (death or serious damage to health), not the number of nonconformities; the measures may include returning the medical device to the manufacturer or its authorized representative. Because the two concepts run on two separate internal processes, misclassification at the intake stage is one of the most common audit findings.

2. Legal basis

3. Expert insights

Insight 1: The dividing line between the two concepts is severity of consequence. Article 5 of Decision No. 174 defines corrective action as action taken by the medical device manufacturer to eliminate the cause of an identified nonconformity or adverse event; field safety corrective action means action taken by the manufacturer to reduce the risk of death or serious deterioration in health associated with the use of the medical device for users or third parties, and such action may include returning the medical device to the manufacturer or its authorized representative. GRZAN note: the two concepts correspond to two internal processes — the former is a routine CAPA, the latter is a post-market field safety action including recall; the trigger thresholds and external communication requirements are entirely different.

Insight 2: Decision No. 106 provides the supporting QMS definitions. That decision defines corrective action as action taken by the manufacturer to eliminate the cause of an identified nonconformity or adverse event; correction as action taken to eliminate an identified nonconformity; and nonconforming medical device as a device that does not meet the applicable requirements. GRZAN note: in the QMS context, correction and corrective action are two different actions — a correction addresses the symptom (such as rework or repair), while a corrective action addresses the cause (such as changing a process or a document). During manufacturing inspections this distinction is verified.

Insight 3: Corrective action is one of the three bases of surveillance. Article 4(c) of Decision No. 174 provides that surveillance is based on the manufacturer’s system for collecting and analyzing safety and effectiveness data in the post-market phase and on corrective actions implemented under the QMS requirements. GRZAN note: this means the execution records of corrective actions are a component of the surveillance system, will be consulted during oversight, and are an object of assessment in manufacturing inspections.

Insight 4: Decision No. 106 also defines the critical supplier. A critical supplier is defined as a supplier whose products or services have a direct impact on the safety and/or effectiveness of the medical device. GRZAN note: if a corrective action involves a critical supplier (for example outsourced sterilization or key components), the action must extend to the supplier level, and disposition records on the supplier side must be retained.

Insight 5: Execution workflow, as applied by GRZAN.

1. Event identification and grading: determine whether a field safety corrective action is triggered (risk of death or serious damage to health) based on the severity of consequences.
2. Cause analysis: distinguish correction (handling the nonconformity that has occurred) from corrective action (eliminating the cause).
3. Measure determination: decide the type of measure, including whether devices must be returned to the manufacturer or its authorized representative.
4. Scope definition: define the affected range by batch or serial number, and include critical suppliers where involved.
5. External communication: report to the competent authority through the reporting route of Decision No. 174, and notify users and the authorized representative.
6. Execution and verification: implement the measures, verify their effectiveness, and retain all records.
7. Integration into the surveillance system: add the disposition records to the post-market data system for use by the unified information database and manufacturing inspections.

4. Practical recommendations

1. Establish a two-level decision standard: state in the CAPA procedure the trigger threshold for a field safety corrective action (risk of death or serious damage to health), so that an action is not left unstarted when it should begin.
2. Separate correction from corrective action: use two distinct fields in CAPA forms so the distinction can be shown directly during manufacturing inspections.
3. Extend measures to critical suppliers: for measures involving critical suppliers, obtain disposition records and remediation evidence from the supplier side.
4. Design the return channel in advance: state in the authorization letter the authority to accept returned medical devices and the logistics arrangements, avoiding ad hoc coordination.
5. Route records into the surveillance system: bring all disposition records into the post-market data system for consultation during surveillance and inspections.

5. Verification checklist

1. □ The trigger threshold for a field safety corrective action (death or serious damage to health) is stated in the CAPA procedure.
2. □ Correction and corrective action are distinguished and given separate fields in the forms.
3. □ It has been determined whether the measures include returning devices to the manufacturer or its authorized representative.
4. □ The affected scope is defined by batch or serial number.
5. □ For measures involving critical suppliers, disposition records from the supplier side have been obtained.
6. □ The competent authority has been notified, users and the authorized representative informed, and submission records retained.
7. □ Disposition records have been added to the post-market data system and are available for surveillance and manufacturing inspections.

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.