Armenia Medical Device Registration: Technical and Biological Testing under EAEU Decisions 28 and 38

1. Key takeaways

Each of the two categories of pre-registration testing in the Union registration system has its own rule: technical tests are governed by Council Decision No. 28 of 2016-02-12, while biological effect trials, studies, are governed by Council Decision No. 38 of 2016-05-16; both were amended on 2022-03-17 by Decision No. 25 and Decision No. 26 respectively. The conclusion of GRZAN: the conditions of applicability are entirely different. In vitro diagnostic reagents and kits are not subject to technical tests, and biological effect trials apply only to devices and their accessories that contact the surfaces of the human body, the mucous membranes or the internal environment of the organism.

2. Legal basis

3. Expert insights

Insight 1: the purpose clauses of the two trial regimes point to the same general requirements. Article 3 of Decision No. 28 provides that technical tests are conducted in order to establish that the medical device conforms to the general requirements approved by Decision No. 27 of the Council of the Eurasian Economic Commission of 2016-02-12; Article 3 of Decision No. 38 likewise provides that biological effect trials serve to establish conformity with those same general requirements. GRZAN points out that this means the starting point for designing a test plan is not a list of standards but the individual items of the general requirements of Decision No. 27; standards are only a means of demonstrating conformity with the general requirements, and the test report should be structured around those items.

Insight 2: the methodological basis of technical tests is the standards list plus the declared technical characteristics. Article 4 of Decision No. 28 provides that when conducting technical tests, the requirements of the standards contained in the standards list apply, on a voluntary basis, in whole or in part to ensure conformity with the general requirements, together with the declared technical characteristics used by the manufacturer to confirm conformity with the general requirements. GRZAN points out that if the standards applied by the product are not in the Union standards list, the manufacturer must demonstrate conformity through the route of declared technical characteristics; this is the principal compliance channel for non-standardized products and should be prepared before submission rather than argued during review.

Insight 3: in vitro diagnostic reagents and kits are expressly not subject to technical tests. Under the current position, technical tests are not conducted for medical devices intended for in vitro diagnostics, meaning reagents and kits. GRZAN points out that this is the largest documentation difference between IVD and non-IVD devices: IVD manufacturers should direct their resources toward performance evaluation and clinical laboratory trials under Annex 5 of Decision No. 29 rather than toward technical tests, and any template that lists technical tests for a reagent should be corrected immediately.

Insight 4: the 2022 amendment expanded the list of products exempt from technical tests. After the amendment, the list of products to which technical tests do not apply was supplemented with quality control materials, calibration materials, cleaning solutions and culture media, on the grounds that technical tests are not applicable to such products. GRZAN points out that IVD supporting products, meaning quality control materials, calibration materials, cleaning solutions and culture media, can therefore be removed from the technical testing segment of the documentation list, which visibly shortens the preparation cycle for product families that include such items.

Insight 5: the scope of biological effect trials is strictly limited. Under the current position, trials and studies aimed at assessing biological action are conducted only for medical devices and/or their accessories that contact the surfaces of the human body, the mucous membranes or the internal environment of the organism. GRZAN points out that devices without body contact, such as in vitro diagnostic instruments, software and certain auxiliary equipment, do not trigger this category of trial; the decisive tool is the classification by nature of contact plus duration of contact, which dovetails with the classification logic of ISO 10993-1.

Insight 6: the 2022 amendment introduced a group extension mechanism. The amended biological effect trial rules allow the study results for a standard sample to be extended to a group of medical devices of the same kind. The preconditions are a group of devices in which the samples are drawn from the same category, manufactured by the same legal manufacturer according to the same technical documentation, with the same composition, meaning materials, and the same scope and conditions of use. GRZAN points out that the selection of the typical sample must reflect the full range of characteristic differences of the homogeneous device group; this is the key argument on which acceptance of the extension depends.

4. Practical recommendations

1. Build an applicability matrix first: determine model by model whether technical tests and whether biological effect trials are required, and write the rationale into the test plan so that the classification is auditable.
2. No technical tests for IVDs: reagents and kits go directly through the performance evaluation and clinical laboratory trial route under Decision No. 29.
3. Use the exemption list to the full: treat quality control materials, calibration materials, cleaning solutions and culture media as exempt from technical tests in line with the 2022 amendment.
4. Argue the group extension in advance: for product lines with many models, organize the typical sample plus group argument first, covering the identity of composition and materials and the sameness of the scope and conditions of use.
5. Use the declared technical characteristics route for non-standard products: for products whose standards are not in the Union list, prepare complete technical characteristic descriptions and verification records.

5. Verification checklist

1. □ The applicability of technical tests has been determined model by model, and IVD reagents and kits have been excluded.
2. □ It has been confirmed that quality control materials, calibration materials, cleaning solutions and culture media fall under the technical-test exemption list.
3. □ The applicability of biological effect trials has been determined by nature of contact plus duration of contact.
4. □ The typical sample argument for group extension has been completed, covering the same manufacturer, the same technical documentation and the same materials.
5. □ Whether the applied standards are in the Union standards list has been confirmed, and technical characteristic descriptions have been prepared for non-standard products.
6. □ The accreditation scope and personnel qualifications of the trial institution have been verified, including the 2-year experience requirement.
7. □ The amendment content of Decisions No. 25 and No. 26 of 2022 has been incorporated into the operating procedures.

Regulatory information verified as of October 30, 2026.

GRZAN service note. GRZAN supports manufacturers in planning technical tests and biological effect trials for Eurasian Economic Union registration, including applicability matrices, group extension arguments, exemption list application and trial institution selection. Regulatory monitoring is updated continuously and confirmed against the official sources cited above. For inquiries, contact info@grzanglobal.com.