Azerbaijan Medical Device Risk Classification: Classes 1, 2a, 2b and 3 Explained

1. Key takeaways

Azerbaijan classifies medical devices by risk into 4 degrees: low (Class 1), medium (Class 2a), high (Class 2b) and higher (Class 3). The classification was approved by Decision No. 8 of the Collegium of the Ministry of Health of May 21, 2024, adopted under the second sentence of Article 6.8 of the Law on Medicinal Products. Every device falls into exactly one risk degree (Article 3.2), and only the three degrees of higher, high and (or) medium require state registration (Article 3.4). Low risk devices are outside the scope of mandatory registration.

The classification is assessed along 8 dimensions (Article 3.1): the duration of use; the probability of harm to patient health and the severity of that harm; whether the device is invasive; whether it is sterile; whether it contacts or interacts with human tissues or organs; the manner of application to the body or route of entry; whether it acts on organs vital to life, including the heart, the circulatory system and the central nervous system; and whether it uses energy. Duration of use is further divided into three groups (Article 3.5): transient (less than 60 minutes of continuous use), short term (60 minutes to 30 days) and long term (more than 30 days).

2. Legal basis

• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of May 21, 2024, on the Classification of Medical Devices by Risk Degree (adopted under the second sentence of Article 6.8 of the Law on Medicinal Products; signed by Minister Teymur Musayev; sent to the Ministry of Justice for entry into the national register of legal acts within 3 days of adoption): Article 3.1 (8 assessment dimensions), Article 3.2 (one device, one degree), Article 3.3 (4 degrees: 3.3.1 low, Class 1; 3.3.2 medium, Class 2a; 3.3.3 high, Class 2b; 3.3.4 higher, Class 3), Article 3.4 (only the higher, high and medium degrees require state registration), Article 3.5 (transient, short term and long term groups), Article 3.8 (independent classification of accessories), Part 4 (invasive devices), Part 5 (non-invasive devices), Part 6 (active devices), Part 7 (IVDs), Part 8 (supplementary provisions).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında, No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Collection of the Republic of Azerbaijan, 2007, No. 2, item 70), as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, item 1127): the normative basis for Articles 3.3 and 3.4.
• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024, approving the Rules on State Registration of Medicinal Products, Drug Substances and Medical Devices, Entry into the State Register and Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Collection 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 with effect from July 20, 2024): Article 1.2.3 (the scope of devices subject to registration).

3. Expert insights

Insight 1: the naming is Classes 1, 2a, 2b and 3, which is not the same as EU Classes I, IIa, IIb and III. Azerbaijan uses a 4-degree structure but calls the top degree higher (Class 3) rather than Class 4. This off-by-one numbering will trip up companies that copy CE classifications into the risk degree field of certificates and dossiers. The field must be filled with the Azerbaijani degree name, not with the CE Roman numerals.

Insight 2: software has its own classification chain. Under Article 6.10, software used to provide decision-making information for patients is in principle medium. Under Article 6.11, if its decisions could lead to death or irreversible deterioration of health status the degree is higher, and if they could lead to serious deterioration or require surgical intervention the degree is high. Under Article 6.12, software monitoring physiological processes is medium. Under Article 6.13, software monitoring vital physiological parameters where direct dangerous consequences are possible is high. Under Article 6.14, all remaining software is low. Software companies must not assume that software is always low risk.

Insight 3: the escalation logic for invasive devices is steep. Article 4.3 takes invasive surgical devices for short term use as the medium baseline, but devices touching the central circulatory system or the central nervous system (Articles 4.3.1 and 4.3.3) jump straight to higher. Devices delivering ionizing radiation energy (4.3.4), devices with a biological effect or those that are wholly or mainly absorbed (4.3.5), and devices used to administer medicines by a potentially hazardous route (4.3.6) jump to high. Conversely, reusable surgical instruments (Article 4.3.2) drop back to low.

Insight 4: nanomaterials and animal-derived products carry separate escalators. Article 8.9 sets three tiers by the likelihood of internal exposure: high or medium exposure means higher, low exposure means high, and very low exposure means medium. Article 8.7 assigns higher to devices manufactured using non-viable or inactivated human or animal tissues, cells and their derivatives, while Article 8.8 downgrades animal-derived products that only contact intact skin to high.

Insight 5: Article 3.8 lets accessories walk their own degree. The risk degree of an accessory is determined independently of the device it is used with. This does not contradict Article 7.10 of the Resolution No. 345 Rules, under which components are registered as part of the set: classification is independent, registration is merged.

4. Practical recommendations

1. When completing the risk degree field in certificates and dossiers, use the Azerbaijani degree wording (low, medium, high, higher, or Classes 1, 2a, 2b and 3), and never enter CE Classes I, IIa, IIb or III.
2. For software products, compare against Articles 6.10 to 6.14 item by item, and determine the consequences of the decision first before assigning the degree.
3. For invasive devices, work through Articles 4.1 to 4.5 step by step to check escalation and downgrading scenarios, especially the rule that reusable surgical instruments drop to low.
4. For products containing nanomaterials or animal-derived components, run the dedicated assessment under Articles 8.7 to 8.9 separately.
5. Classify accessories independently under Article 3.8, but at submission merge them into the set with the main device under Article 7.10.
6. Prepare a one-page classification statement listing the article numbers of Decision No. 8 relied upon, submit it with the dossier and keep it on file for reference.

5. Verification checklist

• □ The item-by-item assessment along the 8 dimensions of Article 3.1 has been completed with a written conclusion.
• □ The duration of use group of the product (transient, short term, long term) has been confirmed.
• □ Under Article 3.2 it has been confirmed that the product falls into a single degree.
• □ Under Article 3.4 it has been confirmed whether the product falls within the three registrable degrees.
• □ Software, nanomaterial and animal-derived products have been routed through the corresponding dedicated articles.
• □ The classification statement has been completed and the cited article numbers marked.

Related reading

• Article 03. The Legal Definition of a Medical Device: the Equivalence Wording of Article 1.0.1 of the Law on Medicinal Products: https://www.grzanglobal.com/azerbaijan-medical-device-registration/legal-definition-of-medical-device/
• Article 06. Low Risk Devices Are Not Registered: the Boundary of Exemption and Import Permits: https://www.grzanglobal.com/azerbaijan-medical-device-registration/low-risk-devices-exemption-and-import-permit/
• Article 12. Classification Determination Before Submission: How to Use the Grading Rules of Decision No. 8: https://www.grzanglobal.com/azerbaijan-medical-device-registration/classification-determination-before-submission/

This article was translated and published by GRZAN, the international regulatory affairs service of GRZAN Global. For professional support with medical device registration in Azerbaijan, regulatory strategy, dossier preparation and local representation, contact us at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.