top of page
Medex EU Authorised Representative logo

EU Authorized Representative for Azerbaijani Medical Device Manufacturers

In Azerbaijan the Analytical Expertise Center of the Ministry of Health registers medicines and medical devices, and since the 2023 amendment to the Law on Medicines a device above risk class I cannot be imported without state registration. A manufacturer in Baku that has worked through that process has a national registration and nothing that the European Union recognises. This page explains the Azerbaijani scheme, the Union requirements under Regulation (EU) 2017/745 and the Article 11 mandate that Medex, from Türkiye, provides.

The Analytical Expertise Center and state registration

The Analytical Expertise Center (AEC) was established in 2007 on the initiative of the Ministry of Health and describes itself as the regulatory authority of the Ministry in the pharmaceutical field; the Ministry of Health lists the Center among its institutions and refers readers to pharma.az. On medical devices, the Center's notice of 30 July 2024 states that under Law No. 979-VIQD of 14 July 2023, amending the Law of the Republic of Azerbaijan "On Medicines", medical devices cannot be imported without state registration, except for medical devices belonging to risk group I. The same notice refers to the Cabinet of Ministers' Rules for State Registration of Medicines, medicinal substances and medical devices and for keeping the State Register.

Two features follow for an exporter. Azerbaijan ties registration to import, so the registration is held on the import side of the border. And the exemption for risk class I means a Class I manufacturer in Azerbaijan may never have filed anything at home.

The Union exempts no class and registers no imports

The Regulation requires conformity assessment for every device, whatever its class, before it is placed on the market:

"Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI."

Regulation (EU) 2017/745, Article 52(1)

A Class I device under Annex VIII still needs an Annex II technical file, an EU declaration of conformity, UDI assignment, EUDAMED registration and a representative. The Union also has no import registration: the importer verifies under Article 13 that the device is CE marked, that an EU declaration exists, that a manufacturer and a representative are identified, that labelling complies and that a UDI has been assigned. An Azerbaijani state registration is not among the documents an EU importer looks for.

The sole representative rule

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative."

Regulation (EU) 2017/745, Article 11(1)

The representative must be established within the Union and must accept the mandate in writing. Article 11(2) makes the mandate effective for at least every device of the same generic device group, and MDCG 2022-16 allows separate representatives for separate groups but only one for any given group. The representative's name goes on the label next to the manufacturer's under Annex I, Section 23.2(d).

Türkiye as the seat of the representative

Medex acts under EUDAMED SRN TR-AR-000057550 from Ankara and İstanbul. The EU-Türkiye Customs Union extends the Union market for medical devices to Türkiye, which MDCG 2022-16 records in its first footnote:

"The ’Union market’ refers to the territories of the European Union Member States, and due to the European Economic Area (EEA) is extended to Norway, Lichtenstein and Iceland, and via the Customs Union Agreement to Turkey."

MDCG 2022-16, footnote 1

The European Commission's Notice to Stakeholders of March 2022 concludes:

"manufacturers established outside the territory of the EU or Turkey only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey."

European Commission, Notice to Stakeholders: EU-Türkiye Customs Union Agreement in the field of medical devices (March 2022), Section I.2

An Azerbaijani manufacturer with Medex as representative therefore covers the Member States and Türkiye on one mandate. For sales in Türkiye, registration of the devices in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, follows as a separate service.

Azerbaijani and Russian files, translation and the apostille

Azerbaijani regulatory files are in Azerbaijani or Russian, neither of which is an official Union language. Medex asks Azerbaijani manufacturers for the EU declaration of conformity and the core technical documents in English, because the representative must answer competent authorities in the language they determine:

"in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;"

Regulation (EU) 2017/745, Article 11(3)(d)

The EU declaration of conformity must also be translated into the language each Member State requires (Article 19(1)), and labels and instructions for use follow Article 10(11). On legalisation, the HCCH status table lists Azerbaijan as a Contracting Party to the Hague Apostille Convention with entry into force on 2 March 2005, and marks the accession as one to which objections have been raised; acceptance of an Azerbaijani apostille in a particular state should be read from that table. The Regulation does not require the mandate to be apostilled. For ÜTS filings in Türkiye, TİTCK's guide TCKKD-KLVZ-03, Article 8, requires an apostilled original of a foreign certificate, with the apostille from the manufacturer's country or from the country of the EU Authorized Representative, or a Turkish consular attestation, or a verifiable e-signed original, with a sworn Turkish translation.

Azerbaijani and Union instruments compared

AzerbaijanUnion (Regulation (EU) 2017/745)Carries across?
State registration by the Analytical Expertise Center, required for import above risk class INo product registration; EU declaration of conformity (Article 19) and certificate under Article 56No
Risk class I exempt from registrationNo exemption; Class I self-declaration under Article 52(7) with full Annex II fileNo
State Register kept under Cabinet of Ministers rulesEUDAMED actor and device registration (Articles 29, 31)Separate systems
Importer holds the registrationImporter verifies the manufacturer's CE marking, declaration and representative (Article 13(2))Roles differ
Azerbaijani or Russian documentationLanguage determined by each Member State's authority; label per Article 10(11)Translation needed

Mandate, EUDAMED and limits

"The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)."

Regulation (EU) 2017/745, Article 11(4)

Medex drafts and accepts the mandate, registers as an actor under Article 31, verifies the manufacturer's registrations under Articles 27 and 29 and keeps the technical documentation and EU declaration of conformity available to competent authorities. Medex is not a notified body and does not issue certificates or carry out conformity assessment. Medex is not an importer or a distributor and does not buy, hold or sell devices. The representative, importer and PRRC roles are separate under the Regulation and stay separate in practice. Fees are published on the pricing page: between EUR 800 and EUR 2,000 per year depending on the MDR or IVDR class, with no setup fee, and fixed for three years from signature.

Frequently asked questions

Our device is risk class I in Azerbaijan and was never registered. Is that a problem in the EU?

No. The Union never asks for a home registration. It asks for conformity assessment under the Regulation, an EU declaration of conformity, UDI, EUDAMED registration and a sole representative. A Class I device under Annex VIII goes through all of these.

Our importer in Baku holds our state registration. Can it act as our EU representative?

No. Article 2(32) requires the representative to be established within the Union, and the Customs Union extends that to Türkiye. An Azerbaijani company cannot hold the mandate. The Azerbaijani importer keeps its role for Azerbaijan.

Do we need an apostille on the mandate?

Not under the Regulation. The HCCH table records the Apostille Convention in force for Azerbaijan since 2 March 2005, with objections from some Contracting Parties. An apostille or a Turkish consular attestation is relevant only for documents uploaded to ÜTS in Türkiye.

Can our technical file stay in Russian?

Russian is not an official Union language. Medex needs the EU declaration of conformity and the core technical documents in a language the competent authority determines, usually English. Labels and instructions for use must be in the language of each Member State where the device is sold.

Does one mandate cover the EU and Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement, and the Commission's Notice to Stakeholders states that a third-country manufacturer needs one representative, in either territory, for both. ÜTS device registration in Türkiye is a separate step.

Sources and further reading

To appoint an EU Authorized Representative for devices made in Azerbaijan, send your device list and current documents through the proposal form. Medex replies with the mandate scope, the EUDAMED steps and the published fee band for your device class.

bottom of page