Armenia IVD Medical Device Registration: Dossier Differences in the EAEU

1. Key takeaways

Under the Union rules, in vitro diagnostic, IVD, medical devices follow a standalone dossier structure: the technical documentation is prepared under Annex 5 of Decision No. 29, reagents and kits are not subject to technical tests, and classification is determined under the criteria aligned with the IMDRF after the 2023 amendment. The conclusion of GRZAN: the documentation weight of an IVD project lies in performance evaluation, covering analytical performance and clinical performance, rather than in the technical tests and biological effect trials that apply to non-IVD devices; copying the dossier template of a general device leads directly to rejection.

2. Legal basis

3. Expert insights

Insight 1: the IVD definition covers reagents, calibration materials, quality control materials, reference materials and test substances in full. Chapter 10 of the Law on Medical Assistance and Services to the Population and Decision No. 27 each define a medical device intended for in vitro diagnostics independently: any instrument, apparatus, device, material, reagent, calibration material, quality control material, reference material, test substance or other product, used alone or in combination, including the accessories and dedicated software required for its intended use, intended for the in vitro examination of human biological samples in order to determine a physiological or pathological state, tissue compatibility with a potential recipient, the prediction of the response to a therapeutic action, the selection of therapeutic agents and/or the monitoring of therapy. GRZAN points out that instruments, reagents, calibration materials, quality control materials and software all belong to the IVD category, but the documentation focus differs for each.

Insight 2: the entry point of the technical documentation is Annex 5 of Decision No. 29. Under Article 35 of Decision No. 106, when applying for a periodic planned production inspection, an in vitro diagnostic device requires the submission of technical documentation conforming to Annex 5 of Decision No. 29, in electronic, searchable form in Russian. GRZAN points out that non-IVD devices follow Annex 3 while IVDs follow Annex 5, and the two must never be mixed; a company operating both IVD and non-IVD product lines should maintain separate technical documentation templates, with the mapping of each section recorded explicitly.

Insight 3: reagents and kits are 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; after the amendment by Decision No. 25 of 2022, the exemption list was further extended to quality control materials, calibration materials, cleaning solutions and culture media. GRZAN points out that IVD manufacturers should concentrate their testing budget on analytical performance studies, covering precision, accuracy, detection limit, linearity, interference and similar parameters, and on clinical performance studies; the former substitutes for technical tests and the latter corresponds to clinical laboratory trials.

Insight 4: the classification rules were aligned with the IMDRF in 2023. When Board Decision No. 65 of 2023-05-23 amended the classification rules, it expressly took into account the changes in the IMDRF documents concerning software as a medical device and in vitro diagnostic medical devices. GRZAN points out that IVD classification is no longer determined by the physical form of the device alone; the risk determination logic of the IMDRF has been incorporated, so the class of some reagents may move up or down, and the classification of legacy products should be reviewed again.

Insight 5: the consolidation of multiple models into one certificate has a dedicated condition for IVDs. Article 19 of Decision No. 46 provides that the consolidation of several models, meaning brands, into a single registration certificate requires all conditions to be met simultaneously, and item d addresses IVDs specifically: the models must be intended to determine the presence and/or the quantitative content of an analyte of the same clinical, diagnostic, significance in biological samples. GRZAN points out that kits for different analytes cannot be consolidated into one registration certificate; this is a hard constraint in IVD product line planning and certificate portfolio design.

4. Practical recommendations

1. Build IVD-specific templates: establish a technical documentation template under Annex 5 of Decision No. 29 and manage it separately from the Annex 3 template used for non-IVD devices.
2. Direct the budget toward performance studies: shift the testing budget from technical tests to analytical performance and clinical performance studies, which carry the evidentiary weight for IVD dossiers.
3. Review the classification after 2023: re-determine the class of legacy IVD products under the amended classification rules and update the documentation list and inspection obligations in step.
4. Plan certificates by analyte: several models directed at the same analyte may be consolidated into one certificate; different analytes must be applied for separately.
5. Handle supporting products separately: treat quality control materials, calibration materials, cleaning solutions and culture media under the technical-test exemption list, but confirm whether each of them constitutes an independent medical device in its own right.

5. Verification checklist

1. □ The product has been confirmed to fall within the IVD definition of Chapter 10, including reagents, calibration materials, quality control materials and software.
2. □ The technical documentation has been prepared under Annex 5 of Decision No. 29, without mixing in the Annex 3 template.
3. □ It has been confirmed that reagents and kits are not subject to technical tests and the budget has been redirected to performance studies.
4. □ The product class has been reviewed again under the classification rules as amended in 2023.
5. □ A consolidation plan for multiple models has been designed on the same-analyte principle.
6. □ It has been confirmed that quality control materials, calibration materials, cleaning solutions and culture media fall under the technical-test exemption list.
7. □ It has been confirmed that the technical documentation is submitted in electronic, searchable form in Russian.

Regulatory information verified as of October 30, 2026.

GRZAN service note. GRZAN supports IVD manufacturers in the Eurasian Economic Union and Armenia with dossier structuring under Annex 5, performance study planning, classification review after the 2023 alignment and certificate portfolio design by analyte. Regulatory monitoring is updated continuously and confirmed against the official sources cited above. For inquiries, contact info@grzanglobal.com.