Armenia Medical Device Classification Update: EAEU Decisions No. 65 and No. 18

1. Key takeaways

The classification rules were amended twice in a row over the last two years: Board Decision No. 65 of 2023-05-23 (aligning with the IMDRF approach and repealing Decisions No. 116 and No. 123 of 2018) and Board Decision No. 18 of 2025-02-18 (downgrading medical antimicrobial wipes from Class 3 to Class 2a). The GRZAN conclusion: the practical impact of classification amendments is chain-like — a class change simultaneously alters the depth of the documentation list, whether a manufacturing inspection is triggered, and the intensity of post-market surveillance, so after every amendment the classification of existing products must be re-verified.

2. Legal basis

3. Expert insights

Insight 1: The first layer of the 2023 amendment is international alignment. As amended by Decision No. 65, the classification rules take into account changes in enforcement practice and the changes in IMDRF documents concerning software as a medical device and in vitro diagnostic medical devices. GRZAN note: this means the Union’s classification approach is converging with the IMDRF; the class determination logic for software and IVD products has changed, and existing products must be re-verified against the new approach.

Insight 2: The second layer of the 2023 amendment is the repeal of old decisions. Decision No. 65 simultaneously declared Decisions No. 116 and No. 123 of 2018-07-24 invalid — these governed the distinction of medical device components and the criteria for merging multiple models into one registration certificate. GRZAN note: after the repeal, the relevant determinations revert to Decision No. 173 and Article 19 of Decision No. 46; internal work standards that still cite the two decisions must be updated immediately.

Insight 3: The 2025 amendment is a quantifiable downgrade that reduces burden. As amended by Decision No. 18, antimicrobial wipes used for cleaning the hands of medical personnel, surgical fields and injection sites are classified as Class 2a. Before the amendment, medical devices containing substances that could be regarded as medicinal products when used separately were placed in Class 3, so ethanol-based wipes fell into Class 3. The rationale is that ethanol here performs only a disinfection function and does not carry the risks inherent in combination products. GRZAN note: the greatest value of the downgrade lies in manufacturing inspections — the mandatory inspection threshold covers sterile Class 2a, Class 2b and Class 3 devices; after the move from Class 3 to Class 2a, non-sterile wipes are no longer subject to mandatory manufacturing inspections, and the administrative burden drops significantly.

Insight 4: Three downstream variables affected by classification, as tabulated by GRZAN.

Insight 5: After the amendments, the wording on harm subjects in Decision No. 173 has been refined. The current Article 1 of Decision No. 173 provides that the rules establish the procedure for classifying medical devices by potential use risk, where the risk manifests as harm to the health of patients caused by the use of the device, as well as harm to the persons operating the device, to other persons, to public health or to the environment. GRZAN note: including public health or the environment among the harm subjects means that classification reasoning cannot consider only the risk to the individual patient — this is especially important in the reasoning for infection-control and drug-containing products.

4. Practical recommendations

1. Re-verify existing classifications after every amendment: establish a trigger mechanism from classification amendments to portfolio re-verification; one round should have been completed after each of the two amendments.
2. Focus on software and IVDs: these two categories are most affected by the 2023 IMDRF alignment and should be re-verified first.
3. Seize downgrade opportunities: check drug-containing or disinfectant-containing products against the downgrade logic of Decision No. 18 to see whether the new approach applies.
4. Update the three downstream variables in parallel: after a class change, update the documentation list, the manufacturing inspection plan and the surveillance duties at the same time.
5. Retire obsolete references: update all internal standards citing Decisions No. 116 and No. 123 to Article 19 of Decision No. 46.

5. Verification checklist

1. □ Confirmed the numbers and dates of the two amendments (No. 65 of 2023-05-23 and No. 18 of 2025-02-18).
2. □ Re-verification of existing product classifications completed, with software and IVDs prioritized.
3. □ Checked whether drug-containing or disinfectant-containing products fall under the downgrade logic.
4. □ Updated the three downstream variables in parallel (documentation list, manufacturing inspections, surveillance duties).
5. □ Retired internal standard entries citing Decisions No. 116 and No. 123.
6. □ Included the public health or environment harm dimension in classification reasoning.
7. □ Established a trigger-based re-verification mechanism for classification rule amendments.

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.