Armenia Biological Evaluation and ISO 10993: Evidence Rules under EAEU Decision No. 38

1. Key takeaways

Tests (studies) of biological action are conducted under Board Decision No. 38 dated 2016-05-16, and the core classification dimensions are nature of contact plus duration of contact. After the amendment introduced by Decision No. 26 dated 2022-03-17, the study results for a typical sample may be extended to a group of similar medical devices. The GRZAN conclusion is that the compliance key in biological evaluation is not the number of tests performed but whether the classification rationale holds up: if the classification is wrong, the test items are wrong, and the entire investment is wasted.

2. Legal basis

3. Expert insights

Insight one: Article 2 provides four key definitions, and they are the toolkit for the classification rationale. Article 2 of Decision No. 38 defines the class of a medical device as the classification characteristic determined when selecting methods for evaluating biological action, depending on the group, type and duration of contact of the device; material as synthetic or natural polymers, metals, alloys, ceramics or other inert materials, including inert biological tissues without metabolic or reproductive potential, used as the medical device or its components; sample of a medical device as the device, or its representative part, that is directly subjected to testing; and typical sample as a sample selected from a group of medical devices of the same class, manufactured by the same legal manufacturer under the same technical documentation and having an identical composition of materials, scope and conditions of use. The GRZAN observation is that the definition of the typical sample is the legal foundation of the 2022 group-extension mechanism.

Insight two: Article 3 ties the purpose of testing to conformity with the general requirements. The article provides that the tests are conducted in order to establish the conformity of a medical device with the general requirements for safety and effectiveness, labelling and operational documentation approved by Decision No. 27. The GRZAN observation is that the evidence chain of biological evaluation must ultimately return to the provisions of Decision No. 27; it cannot stop at the level of the test report itself.

Insight three: the four contact categories connect to ISO 10993-1. Following the classification logic of ISO 10993-1, medical devices are classified by the nature of body contact as non-contact devices (for example, blood collection tubes), surface-contacting devices (skin and mucous membranes, for example electrodes), externally communicating devices (blood path, tissue, bone or dentine contact, for example laparoscopes and infusion sets) and implant devices (for example, cardiac pacemakers). By duration of contact they are classified as short-term exposure of up to 24 hours, prolonged exposure from 24 hours to 30 days and long-term exposure exceeding 30 days. The practical estimate is that these classifications apply at union level in the form of the relevant interstate or national standards, and test plans should follow the versions listed in the union standards list (practical estimate).

Insight four: the 2022 amendment introduced two substantive changes. Under the amended rules: first, the study results for a typical sample may be extended to a group of similar medical devices, reducing the time and financial costs that manufacturers incur for studies; second, the formats of the technical test records and the biological evaluation test records were refined, and the mandatory work experience for laboratory professionals was reduced from 3 years to 2 years. The GRZAN observation is that a group extension must satisfy the four-way consistency in the typical sample definition of Article 2 — same legal manufacturer, same technical documentation, identical material composition, same scope and conditions of use — and the typical sample must reflect the full range of differences among the homogeneous devices of the group in the characteristics of individual models.

Insight five: the scope of biological action testing is expressly limited. Under the current position, tests aimed at evaluating biological action are conducted only for medical devices and/or their accessories that contact the surface of the human body, mucous membranes or the internal environment of the body. The GRZAN observation is that non-contact devices — in vitro diagnostic instruments, standalone software and some auxiliary equipment — do not trigger such testing, and a written determination of not applicable should be recorded in the dossier to prevent requests to perform tests retroactively.

4. Practical recommendations

1. Classify before testing: issue a written classification rationale by nature of contact (4 categories) and duration of contact (3 bands), and derive the test items from it.
2. Record a not-applicable determination for non-contact devices: issue a reasoned document stating that biological action testing does not apply, citing the applicable position.
3. Use the group extension fully: for product lines with many models, organise the rationale under the typical sample definition of Article 2 and write the extension mechanism into the test plan.
4. Make the typical sample cover the differences: the selected sample must reflect the full range of variation across the group in the characteristics of individual models; explain each item in the rationale.
5. Verify laboratory credentials: check the 2-year professional experience requirement of the laboratory staff and the scope of its accreditation.

5. Verification checklist

1. □ A written classification rationale by nature and duration of contact has been completed.
2. □ Whether the device falls within the scope of devices contacting the body surface, mucous membranes or the internal environment has been confirmed.
3. □ A not-applicable rationale document has been issued for non-contact devices.
4. □ The typical sample rationale for group extension is complete (four-way consistency plus difference coverage).
5. □ The accreditation scope of the testing laboratory and the 2-year staff experience requirement have been verified.
6. □ The evidence mapping to the provisions of Decision No. 27 has been established for biological evaluation.
7. □ The amendment content of Decision No. 26 of 2022 has been incorporated into the working standards.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with biological evaluation for the Armenian market, from contact classification rationales and typical-sample group extensions to laboratory selection and evidence mapping against Decision No. 27. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.