Armenia Medical Device Risk Classification 2026: EAEU Decision No. 173 and Downstream Obligations

1. Key takeaways

Medical devices in the Eurasian Economic Union are classified into Class 1, Class 2a, Class 2b and Class 3, covering four potential-use risk levels. The rules were established by EEC Board Decision No. 173 of 2015-12-22 and have undergone two amendments in recent years (No. 65 of 2023 and No. 18 of 2025). The GRZAN judgment: classification is not a technical label but the master switch for three downstream variables — the thickness of the documentation list, whether a manufacturing site inspection is triggered, and the intensity of post-market surveillance. Misclassification is the most expensive category of error in a registration project, because it occurs before any testing investment has been made, and correcting it invalidates work that has already been planned, quoted and scheduled. The 2023 and 2025 amendments also show that the classification landscape is still moving, so a classification set today must be re-verified against the current consolidated text before submission.

2. Legal basis

3. Expert insights

Insight 1: the object of classification is the harm caused by the potential risk of use, and the definition was refined by the 2023 amendment. Article 1 of the current Decision No. 173 provides that the rules establish the procedure for classifying medical devices according to the potential risk of their use, where the risk manifests itself as harm to the health of patients caused by the use of the medical device, as well as harm to the personnel operating the device, to other persons, to public health or to the environment. GRZAN notes that the 2023 amendment wrote public health and the environment explicitly into the list of harm subjects, which means that a classification argument can no longer be built solely on risks to the individual patient.

Insight 2: Decision No. 65 of 2023 did two things at once: absorption and repeal. On one side it absorbed the latest positions of the International Medical Device Regulators Forum (IMDRF) on software as a medical device and on in vitro diagnostic medical devices, bringing Union classification closer to international practice. On the other side it declared EEC Board Decisions No. 116 and No. 123 of 2018-07-24 invalid — the two decisions that had governed the distinction of constituent elements of medical devices and the criteria for combining multiple models into one registration certificate. After the repeal, the related judgments revert to Decision No. 173 and to Article 19 of Decision No. 46.

Insight 3: Decision No. 18 of 2025 is a model case of down-classification to reduce burden. Before the amendment, medical devices containing substances that could be regarded as medicinal products when used on their own were placed in Class 3, so antiseptic wipes containing ethanol fell into Class 3. After the amendment, antiseptic wipes used by medical personnel for cleaning hands, surgical fields and injection sites are expressly classified as Class 2a. The rationale is that ethanol here performs only a disinfecting function and does not present the risks inherent in drug-containing devices. GRZAN notes the direct consequence of down-classification: such products no longer automatically trigger a manufacturing site inspection (the mandatory thresholds for inspection are sterile Class 2a, Class 2b and Class 3), which materially lowers the administrative burden.

Insight 4: the linkage table between classification and downstream obligations is an essential tool at project initiation.

4. Practical recommendations

1. Classification precedes everything: complete and archive the classification argument before any testing contract is signed, citing the specific provisions of Decision No. 173 relied upon.
2. Review down-classification opportunities annually: the amendments of 2023 and 2025 show that the classification rules are in an active revision cycle, and existing products should be re-examined against the new readings for down-classification potential.
3. Apply the new readings to software and IVD: argue these two categories under the IMDRF-aligned readings introduced by the 2023 amendment, and do not reuse the old classification logic.
4. Enter the classification into product master data: carry the risk class as a master-data field, linked to the NMI code and the manufacturing inspection status so that changes propagate automatically.

5. Verification checklist

1. □ The classification argument has been completed and cites the specific provisions of Decision No. 173.
2. □ It has been confirmed that the classification rules in force are the version after amendments No. 65 of 2023 and No. 18 of 2025.
3. □ Whether the product falls into sterile Class 2a, Class 2b or Class 3, and hence whether a manufacturing inspection is mandatory, has been confirmed.
4. □ It has been confirmed that software and IVD products apply the classification readings as amended in 2023.
5. □ It has been confirmed that Decisions No. 116 and No. 123, cited in the past, are no longer relied upon.
6. □ A four-way linkage table of classification, documentation, inspection and surveillance has been established.
7. □ An annual classification review point has been set to track down-classification opportunities.

Regulatory information verified as of October 30, 2026.

GRZAN services. GRZAN International performs EAEU classification assessments, down-classification reviews and linkage planning for documentation, inspection and surveillance obligations. For inquiries, contact info@grzanglobal.com.