Armenia EAEU Technical File and Risk Management: Decision No. 27 General Requirements

1. Key takeaways

Decision No. 27 is the only union-level instrument that sets out substantive safety and effectiveness requirements, and risk management must be implemented according to the four-step priority order of its Article 4: identify hazards and evaluate the associated risks, then eliminate the risks through design and manufacturing, then reduce the residual risk through protective measures, and finally inform users of any residual risk. The GRZAN conclusion is that the technical file is not a stack of standards; it is an evidence matrix mapped clause by clause against the general requirements of Decision No. 27. The most common reason for a file being returned is having standards on one side and nothing on the other — standards without a corresponding demonstration.

2. Legal basis

3. Expert insights

Insight one: Article 4 sets out an order, not a menu of options. The article requires the manufacturer, when taking decisions on the design and manufacture of a medical device, to comply with the safety principles and take account of the generally acknowledged state of the art, managing risks where necessary so that the residual risk associated with any hazard is acceptable. The manufacturer follows the principles in order of priority: first, identify known or foreseeable hazards and evaluate the risks associated with using the device for its intended purpose and in foreseeable misuse; second, eliminate the risks through appropriate technical and process solutions in design and manufacture; third, reduce the residual risk by taking appropriate protective measures, including alarms; fourth, inform users of any residual risk. The GRZAN observation is that the risk management file must visibly reflect this sequence — jumping straight from hazard identification to informing users, without documenting design-based elimination, is a structural defect reviewers routinely flag.

Insight two: Articles 5 to 8 form four performance guarantees. Article 5 requires the design, manufacture and packaging of the device to be such that its characteristics and performance are not impaired during transport and storage carried out as instructed. Article 6 requires the device to be effective as intended by the manufacturer and to conform to its intended use under normal operating conditions. Article 7 requires that within the service life determined by the manufacturer, the performance characteristics and effectiveness of the device do not degrade to a degree that endangers the life or health of users or third parties, assuming the influences that may occur under normal working conditions and maintenance as instructed. Article 8 requires all known and foreseeable risks and undesirable effects arising from the use of the device to be minimised and to be acceptable in comparison with the benefits the manufacturer expects the device to bring to the user. The GRZAN observation is that Article 7 is the substantive legal basis for shelf-life and stability validation, while Article 8 is the substantive legal basis for the benefit-risk argument; each needs its own standalone document.

Insight three: Article 9 elevates information provision to a general requirement. The article requires that information be provided for every medical device sufficient to identify the device, its manufacturer and its country of origin, together with information for the user, professional or non-professional, on the safety of the device, its functional attributes and its operating characteristics. This information may be located on the device itself, on the packaging or in the instructions for use. The GRZAN observation is that information is itself a compliance element: a missing or incorrect marking is a failure against the general requirements, not a mere formal defect.

Insight four: the recommended construction of the evidence matrix (the GRZAN working method).

Insight five: standards are the route to compliance, not the substance of compliance. Article 4 of Decision No. 28 provides that technical tests apply the standards listed in the standards list, which on a voluntary basis secure conformity with the general requirements in whole or in part, together with the declared technical characteristics used by the manufacturer to confirm conformity. The GRZAN observation is that when the standards applied to a product are not in the union standards list, the demonstration should proceed through the declared technical characteristics route: the manufacturer declares the technical characteristics itself and supplies verification records to support each declaration.

4. Practical recommendations

1. Build the evidence matrix clause by clause: use the six-row matrix above as the template, assigning a document and an owner to every row, so no file ends up with standards but no correspondence.
2. Reflect the four-step order in the risk management file: distinguish explicitly between hazards eliminated by design and residual risks reduced by protective measures, and map every residual risk to a warning in the instructions for use.
3. Keep shelf-life and benefit-risk documents separate: do not fold stability data into the risk management file; the two are reviewed from different angles.
4. Use the declared characteristics route for non-standard products: prepare the characteristics statement and verification records early, and justify the approach in the technical test plan.
5. Proofread information documents independently: review labelling and instructions for use as a separate exercise under Article 9, focusing on manufacturer identification and country of origin.

5. Verification checklist

1. □ A matrix mapping the provisions of Decision No. 27 to evidence documents has been established.
2. □ The risk management file reflects the four-step priority order of Article 4.
3. □ Transport and storage validation documentation required by Article 5 has been issued.
4. □ Shelf-life and stability documentation required by Article 7 has been issued.
5. □ The benefit-risk argument required by Article 8 has been issued.
6. □ Labelling and instructions for use have been independently proofread against Article 9.
7. □ Declared technical characteristics statements and verification records are ready for non-standard products.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives in building technical files and risk management documentation for the Armenian market, from clause-by-clause mapping against Decision No. 27 to validation planning and standards strategy. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.