Azerbaijan Device Classification vs EU MDR: Four Risk Degrees and Three Key Differences

1. Key takeaways

Azerbaijan classifies devices into four risk degrees: low (Class 1), medium (Class 2a), high (Class 2b) and higher (Class 3) (Article 3.3 of Decision No. 8). Structurally it resembles the EU classes I, IIa, IIb and III, but there are three points that cannot simply be copied across:

First, the numbering is offset by one. The top Azerbaijani degree is Class 3 — there is no Class 4 following the III class of the EU ladder.

Second, the classification result is made by the agency determined by the Ministry of Health, not self-assessed by the manufacturer. The second sentence of Article 6.8 of the Law on Medicines assigns classification competence to the agency determined through the relevant executive authority; although Article 4.2.8 requires the manufacturer to state the risk degree in the declaration of conformity, that statement is only a declaration by the manufacturer.

Third, the dossier contains no clinical evaluation, no UDI and no notified body involvement. The 11 items of Article 4.2 include no clinical evaluation report and no UDI field — the 7 Register fields carry the GMDN code (Article 10.4.6) but no UDI.

(The detailed rules of the EU MDR are outside the official verification scope of this series; this article is provided for comparison only, and EU-side determinations should be checked against the official EU texts.)

2. Legal basis

• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of 21 May 2024 on the Classification of Medical Devices by Risk Degree (adopted under the second sentence of Article 6.8 of the Law on Medicines; signed by Minister Teymur Musayev; to be sent to the Ministry of Justice for inclusion in the National Register of Legal Acts within 3 days of adoption): Articles 3.3.1 to 3.3.4 (four degrees: low — Class 1, medium — Class 2a, high — Class 2b, higher — Class 3), Article 3.2 (one device falls into one degree only), Article 3.4 (only Class 3 requires registration), Articles 6.10 to 6.14 (software classification), Articles 7.3 to 7.8 (IVD classification), Article 8.9 (nanomaterials).
• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of 18 July 2024 approving the Rules for the State Registration of Medicines, Pharmaceutical Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (in force from 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Collection 2024, No. 7, Article 906; repealing Resolution No. 108 of 13 July 2007 with effect from 20 July 2024): Article 1.2.3 (scope of items requiring registration), Article 4.2 (the 11 dossier items, with no clinical evaluation item), Article 10.4.6 (GMDN code), Article 4.2.8 (the declaration of conformity must state the risk degree).
• Law of the Republic of Azerbaijan on Medicines (No. 208-IIIQ, adopted 22 December 2006, in force 28 February 2007, Legislative Collection 2007, No. 2, Article 70), as amended by Law No. 979-VIQD of 14 July 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, Article 1127): second sentence of Article 6.8 (classification competence), Article 1.0.8 (definition of State registration).

3. Expert insights

Insight one: a wrong degree name propagates all the way into the public fields. Article 10.4.3 (Register risk degree) and the Annex 5 certificate (risk degree of the medical device) both require the Azerbaijani local degree. Writing Class IIb directly, or mistaking it for Class 3, conflicts with the classification determination note and can fall into the document-inconsistency ground of Article 5.1.4.

Insight two: software classification is a self-contained Azerbaijani system. Articles 6.10 to 6.14 grade by decision consequence: possible death or irreversible deterioration maps to higher; possible serious deterioration or surgical intervention maps to high; monitoring of physiological processes maps to medium; the rest to low. The approach resembles Rule 11 of the EU MDR but the wording differs, and EU conclusions cannot simply be transcribed into the Azerbaijani fields.

Insight three: IVD classification is built on independent rules, not on the A to D classes of the EU IVDR. Article 7.3 (higher), Article 7.4 (blood group and tissue typing markers, high or higher), Article 7.5 (13 categories, high), Article 7.6 (self-testing, medium), Article 7.7 (general consumables and specimen containers, low) and Article 7.8 (default, medium). This is a structure of six rules over four degrees, and it is not a mapping of the IVDR A/B/C/D classes.

Insight four: the dossier depth differs so much that a CE technical file cannot serve directly as an Azerbaijani dossier. The 11 items of Article 4.2 include no clinical evaluation report, no risk management file, no UDI and no post-market surveillance plan. Conversely, what Azerbaijan requires and a CE technical file normally lacks are: the notarised Azerbaijani translation of the foreign registration certificate or FSC (item 4.2.2), the notarised Azerbaijani translation of the sterile device data (item 4.2.7), and the notarised translation of the instructions for use of drug-containing devices (item 9.1). For CE holders, the workload lies not in the technical content but in localisation and notarisation.

Insight five: Article 3.8 classifies accessories separately, unlike the EU treatment of accessories as following the device. Azerbaijan determines the risk degree of an accessory (ləvazimat) independently of the main device (Article 3.8), while components (komplektləşdirici) are registered with the whole set (Article 7.10). Keeping the two concepts apart is a distinctive design of the local system.

4. Practical recommendations

1. Use the Azerbaijani local degree wording throughout the certificate and the dossier; never enter CE Roman numerals.
2. Reclassify software under Articles 6.10 to 6.14 without reusing EU conclusions.
3. Reclassify IVDs under Articles 7.3 to 7.8 without attempting an A/B/C/D mapping.
4. Run a dossier-gap analysis before entry: what is missing is the notarised translations and local-format documents, not the technical content.
5. Handle accessories and components separately: accessories get an independent classification, components are registered with the whole set.
6. Record in the classification determination note the correspondence between the EU degree and the Azerbaijani degree, with reasons, for later explanations.

5. Verification checklist

• □ The certificate and the dossier use the Azerbaijani local degree wording.
• □ Software has been reclassified under Articles 6.10 to 6.14.
• □ IVDs have been reclassified under Articles 7.3 to 7.8.
• □ A dossier-gap analysis has been completed with a list of required notarised translations.
• □ Accessories and components are handled separately (independent classification, registration with the whole set).
• □ The classification determination note records the EU-to-local degree correspondence.

• Article 05 — The four risk degrees: low, medium, high and higher (Classes 1, 2a, 2b and 3): https://www.grzanglobal.com/azerbaijan-medical-device-registration/four-risk-degrees-class-1-2a-2b-3/
• Article 12 — Classification determination before submission: how to apply the rules of Decision No. 8: https://www.grzanglobal.com/azerbaijan-medical-device-registration/classification-determination-before-submission/
• Article 17 — Differentiated IVD requirements: Section 7 of the classification and the exemption clauses: https://www.grzanglobal.com/azerbaijan-medical-device-registration/ivd-specific-requirements/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and post-market compliance documentation for the Azerbaijan market, from risk degree mapping and software and IVD reclassification to notarised translation management. For tailored assistance with your Azerbaijan medical device documentation, contact us at info@grzanglobal.com.