Armenia Medical Device Definition 2026: Device, Drug and IVD Boundary Rules

1. Key takeaways

The Armenian definition of a medical device is fully merged into the Union framework, and the decisive test is whether the intended principal function is achieved through pharmacological, immunological, genetic or metabolic means, which are the four modes of action that exclude device status. The GRZAN screening rule: a product whose principal intended action is not achieved by pharmacological, immunological, genetic or metabolic means is a medical device; even where a medicinal product assists the action in the course of use, the product is still handled as a medical device. Standalone software is written explicitly into the definition — standalone software is regarded as an active medical device. In vitro diagnostics (IVD) have a separate definition and are subject to separate documentation and testing requirements, which must not be borrowed from the non-IVD pathway.

2. Legal basis

3. Expert insights

Insight 1: the national definition and the Union definition are two landings of the same text. The definition of a medical device given in Chapter 10 of the Law On Medical Assistance and Services to the Population is structurally identical to the definition in Article 2 of Decision No. 27: instruments, apparatus, devices, materials and other products, used alone or in combination for medical purposes, including the accessories necessary for the intended use (including dedicated software); the purposes cover prevention, diagnosis, treatment, medical rehabilitation, monitoring of the state of health of the human body, medical research, replacement, alteration or restoration of anatomical structures or physiological functions, and prevention or artificial termination of pregnancy; and the principal intended action is not achieved in or on the human body by pharmacological, immunological, genetic or metabolic means, although it may be assisted by such means. GRZAN notes that Article 2 of Decision No. 27 also states that standalone software is regarded as an active medical device; the national text carries this through in the form of the phrase including dedicated software, and in practice the stricter Union reading should be applied.

Insight 2: the handle for drug-device combinations is the principal mode of action. The qualifier that the action may be assisted by pharmaceuticals is the key exception. Drug-coated stents and antibiotic-loaded bone cement achieve their principal function through physical or structural means and are registered as medical devices; where the principal function is achieved by the medicinal substance, the product falls into the medicinal product track. This single judgment determines the competent authority and the entire documentation system, and it is the highest-priority decision at project initiation.

Insight 3: the IVD definition sweeps in reagents, calibrators, control materials and reference materials. Both Chapter 10 and Decision No. 27 define devices for in vitro diagnosis separately: any instrument, apparatus, device, material, reagent, calibrator, control material, reference material, test substance or other product, used alone or in combination, including necessary accessories and dedicated software, intended for in vitro examination of specimens from the human body in order to determine a physiological or pathological state (congenital pathology, susceptibility to a particular clinical condition or disease), tissue compatibility with a potential recipient, prediction of response to therapy, or selection of and monitoring of therapeutic agents. GRZAN notes: IVDs are exempt from technical testing (see article 17 of this series), which differs completely from the handling of non-IVD devices.

Insight 4: the characterization result directly determines three downstream variables. It determines which classification rule applies (Board Decision No. 173), which documentation list is submitted (Annex 4 of Council Decision No. 46), and whether a manufacturing site inspection is triggered (Council Decision No. 106). One wrong step in characterization makes all three subsequent steps wrong, and the rework cost concentrates in the testing work that has already been completed and paid for.

4. Practical recommendations

1. Characterize at project initiation: complete a characterization memorandum before the technical specification is frozen, stating the reasoning and the cited provisions for the principal mode of action.
2. Argue the principal function first for drug-containing products: prepare a mode-of-action justification that demonstrates at the mechanism level that the principal function is not achieved by pharmacological, immunological, genetic or metabolic means, and pre-assemble a set of answers to the questions the authority is most likely to raise.
3. Handle software separately: submit standalone software for classification and documentation as an active medical device in its own right; do not merge it into a hardware submission as an accessory, unless it does not itself constitute an independent medical device.
4. Build a separate IVD dossier: prepare IVD products under the IVD documentation structure, and never transplant the technical testing requirements of non-IVD devices.

5. Verification checklist

1. □ A product characterization memorandum has been issued stating the principal mode of action.
2. □ The characterization of standalone software in Article 2 of Decision No. 27 has been checked.
3. □ The carry-through of the phrase including dedicated software in the Chapter 10 definition has been checked.
4. □ A mode-of-action justification has been completed for drug-containing products.
5. □ It has been confirmed that IVD products follow the separate IVD definition and documentation structure.
6. □ The classification rule entry corresponding to the characterization result has been confirmed.
7. □ Whether the characterization result triggers a manufacturing site inspection obligation has been confirmed.

Regulatory information verified as of October 30, 2026.

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