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EU Authorized Representative for Iraqi Medical Device Manufacturers

Iraq's medical device market is organised around the Ministry of Health, whose State Company for Marketing Drugs and Medical Appliances, Kimadia, is the central buyer for the public sector and requires products to be registered with the competent authority in Iraq. A manufacturer in Baghdad, Basra or Erbil that wants to sell in the European Union meets a different structure altogether: no central buyer, no national registration, and a Regulation that requires a sole representative established in the Union. This page sets out the Union requirements and how Medex, from Türkiye, meets them.

The Iraqi starting point

In Iraq the Ministry of Health is the home authority for medicines and medical appliances. Its State Company for Marketing Drugs and Medical Appliances, known as Kimadia, publishes the Ministry's tender documents; those documents state that products supplied under a contract shall be registered with the competent authority in Iraq, that a bidder submits a copy of its registration certificate with its bid, and that the contracting entity cooperates with the successful bidder to facilitate registration within Iraq. For an Iraqi manufacturer the practical consequence is that the home market is largely a procurement market in which registration and tender success go together.

None of that structure exists in the Union. There is no central buyer, no registration certificate issued by a ministry and no tender that doubles as market access. Each Member State buys through its own hospitals and distributors, and every device that reaches them must already carry the CE marking under the Regulation.

What the Union requires instead

"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)

The manufacturer builds Annex II technical documentation, draws up an EU declaration of conformity under Article 19, obtains a notified body certificate under Article 56 for Class IIa and above, assigns a UDI and registers the device in EUDAMED. Evidence prepared for an Iraqi registration, including test reports and quality system records, can be reused in the technical documentation, but no Iraqi document is accepted in place of any of these steps.

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 is defined in Article 2(32) as a person established within the Union acting under a written mandate. It is not an agent, a distributor or a tender partner. Article 11(5) ties the representative's liability to the manufacturer's compliance with Article 10, which is why Medex reviews the EU declaration of conformity and the technical documentation before accepting a mandate:

"where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer."

Regulation (EU) 2017/745, Article 11(5)

A representative in Türkiye for the whole Union

Medex acts under EUDAMED SRN TR-AR-000057550 from offices in Ankara and İstanbul, with a further office in Gdańsk. The EU-Türkiye Customs Union extends the Union market for medical devices to Türkiye, which MDCG 2022-16 states 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 adds that a manufacturer established outside the EU and Türkiye needs to designate only one representative, in either territory, to place devices on the market in both. An Iraqi manufacturer with Medex as representative therefore covers the Member States and Türkiye on one mandate; device registration in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, is a separate step for Turkish sales that Medex also runs.

Documents from Iraq: Arabic, translation and legalisation

Iraqi files are usually in Arabic, sometimes in English. Arabic is not an official Union language, so Medex asks Iraqi manufacturers for the EU declaration of conformity and the core technical documents in English, which allows a request from a competent authority to be answered in the language that authority determines:

"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 be translated into the language each Member State requires under Article 19(1), and labels and instructions for use follow Article 10(11). On legalisation, the HCCH status table of the Apostille Convention does not list Iraq. An apostille cannot be obtained in Iraq, and any document that must be legalised for use abroad goes through the consular route. The Regulation does not require the mandate to be legalised at all. For ÜTS filings in Türkiye, TİTCK's guide TCKKD-KLVZ-03, Article 8, provides for an attestation by the Turkish embassy or consulate in the manufacturer's country, or in the country of the EU Authorized Representative, as an alternative to an apostille, and accepts a verifiable e-signed original from the issuing notified body.

Iraqi and Union positions compared

IraqUnionCarries across?
Registration with the competent authority as a condition of Ministry of Health tendersNo product registration; EU declaration of conformity (Article 19) and CE marking (Article 20)No
Kimadia as central public buyerHospitals and distributors in each Member State; importer duties under Article 13No equivalent
Registration certificate submitted with the bidImporter verifies CE marking, EU declaration, representative and UDI (Article 13(2))Different document set
Arabic documentationLanguage determined by each Member State's authority; label per Article 10(11)Translation needed
No apostille availableNot required by the Regulation; Turkish consular attestation for ÜTSConsular route

Mandate and EUDAMED

"The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group."

Regulation (EU) 2017/745, Article 11(2)

Medex drafts the mandate to the tasks of Article 11(3), accepts it in writing and registers as an actor under Article 31. The manufacturer registers for its own single registration number, and Medex verifies the device registrations under Articles 27 and 29 before devices ship. Manufacturers without an SRN start with the EUDAMED registration service. 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

We supply Iraqi hospitals through Kimadia tenders. Does that experience count for the EU?

As evidence of a working quality system and of product testing, yes. As market access, no. The Union has no tender-based entry and no ministry registration. Conformity assessment under the Regulation, an EU declaration of conformity, UDI, EUDAMED registration and a sole representative are required.

We cannot get an apostille in Iraq. Does that stop the mandate?

No. The Regulation requires a written mandate accepted in writing and nothing more. Legalisation matters only for ÜTS filings in Türkiye, where TİTCK accepts a Turkish consular attestation or a verifiable electronic signature in place of an apostille.

Our Arabic technical file is complete. What does Medex need?

The EU declaration of conformity and the core technical documents in English, so that a competent authority can be answered in the language it determines under Article 11(3)(d). Medex arranges further translation when an authority requires another language.

Can Medex also act as our importer in the Union?

No. Medex acts as representative under Article 11 and does not buy, hold or sell devices. The importer is the EU company that places the device on the Union market and verifies under Article 13(2)(b) that a representative has been designated.

Does one mandate cover Türkiye too?

Yes. MDCG 2022-16 records 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. Device registration in ÜTS is a separate step.

Sources and further reading

To appoint an EU Authorized Representative for devices made in Iraq, 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.

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