Armenia Medical Devices Classified as Measuring Instruments: EAEU Decision No. 42 List

1. Key takeaways

Some medical devices are, at registration, classified as measuring instruments, and the list of such devices is approved by Board Decision No. 42 dated 2016-02-12. The GRZAN conclusion is that products falling within the list must handle type approval of the measuring instrument in addition to the usual registration file. The test is whether the device determines medical characteristic quantities by measurement; the list states this through four substantive columns — device type, name and unit of the measured quantity, measurement range and maximum permissible error — and a hit is a hard requirement, not a discretionary matter.

2. Legal basis

3. Expert insights

Insight one: the list is a six-column structure of type plus metrological characteristics. The list approved by Decision No. 42 is organised in six columns: first, the type of medical device; second, the medical characteristics and quantities determined by measurement; third, the name and unit of the measured quantity; fourth, the measurement item; fifth, the measurement range; sixth, the maximum permissible error. The GRZAN observation is that this structure means the determination is made not by product name but by measuring function and quantity; different models sold under the same product name may fall on opposite sides of the list.

Insight two: typical device types and their metrological parameters. The list includes, among others: the medical audiometer (measured quantity: sound intensity in dB; measurement ranges of 125–4000 Hz and 4000–8000 Hz; maximum permissible errors of 3 dB and 5 dB respectively); the medical scale (measured quantity: weight in kg; measurement ranges of 0.5–15 kg and 15–150 kg; maximum permissible errors of 0.01 kg and 0.1 kg respectively); the medical dynamometer (measured quantity: force in daN; measurement range of 5–500 daN; maximum permissible error of 5%); the clinical universal dosimeter for radiation therapy (measured quantities: absorbed dose in Gy, absorbed dose rate in Gy/s and energy in MeV; measurement range of 0.5–10.0 Gy; maximum permissible error of 3% for external irradiation and 5% for intracavitary and interstitial irradiation); and the clinical X-ray dosimeter (measured quantities: absorbed dose in air in Gy, absorbed dose rate in Gy per square centimetre). The GRZAN observation is that these error parameters are statutory ceilings; the product specification must meet or outperform the listed values.

Insight three: a hit on the list creates dual-track obligations of registration plus metrology. The GRZAN observation is that devices on the list must, in addition to union registration under Decision No. 46, go through type approval or measuring instrument recognition under metrology requirements. Because the division of responsibilities between union-level metrology legislation and national metrology authorities differs across member states, the concrete route and competent authority must be confirmed against the current Armenian metrology legislation and published practice (practical estimate).

Insight four: the error parameters must be written back into the specifications and the labelling. The maximum permissible errors given in the list are hard technical thresholds. The GRZAN observation is that companies should declare the measurement range and maximum permissible error explicitly in the product specification and compare them item by item with the listed values; where the product’s figures are worse than the listed values, the dossier cannot pass the review.

Insight five: the interface with Annex 4 of Decision No. 46. For products on the list, the registration dossier under Annex 4 must be supplemented with metrology-related documents. The GRZAN observation is that such documents typically include the type approval certificate or measuring instrument recognition document together with its Russian translation; they should be prepared in parallel with the registration dossier, so that a mid-review request does not trigger the clock-stop mechanism of Article 14 of Decision No. 46.

4. Practical recommendations

1. Compare against the list at project start: screen every model against the Decision No. 42 list using the four elements of type, measured quantity, measurement range and maximum permissible error.
2. Design the error margins in advance: write the listed maximum permissible errors into the product specification as hard constraints on design inputs.
3. Start metrology in parallel: for products on the list, handle type approval in parallel with registration rather than in series, so neither waits on the other.
4. Prepare the documents together: have the type approval or recognition documents and their Russian translations ready alongside the registration dossier.
5. Certify translations under the reference-state procedure: attach Russian translations of foreign-language metrology documents and certify them under the reference-state procedure required by Decision No. 46.

5. Verification checklist

1. □ Every model has been screened against the Decision No. 42 list (type, measured quantity, measurement range, maximum permissible error).
2. □ The error figures in the product specification are no worse than the listed values.
3. □ The additional metrology steps and the competent authority for listed products have been identified (practical estimate noted).
4. □ Metrology-related documents and their Russian translations are ready.
5. □ Foreign-language metrology documents have been certified under the reference-state procedure.
6. □ Metrology activities are on the project Gantt chart, running in parallel with registration.
7. □ The current version of the list has been confirmed, including a check for subsequent amendments.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with measuring instrument obligations for the Armenian market, from Decision No. 42 list screening and error-parameter design inputs to type approval planning and bilingual document preparation. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.