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EU Authorized Representative for Qatar: Brand Owners, Article 2(30) and the Mandate

Qatar's Ministry of Public Health regulates medicines and pharmaceutical products through its Pharmacy and Drug Control Department. A Qatari company that owns a device brand, whether the device is made in Doha or by a contract factory abroad, meets Regulation (EU) 2017/745 as a manufacturer under Article 2(30) the moment its name goes on a device sold in the Union, and must designate a sole authorized representative under Article 11(1) before that happens. This page explains the manufacturer question, the mandate, EUDAMED, the position of Qatari documents abroad (Qatar is not a party to the Apostille Convention) and why one mandate with Medex covers the Union and Türkiye.

Who regulates in Doha, and what that page actually says

In Qatar the Ministry of Public Health (moph.gov.qa) houses the Pharmacy and Drug Control Department. The department's own page lists its functions: proposing drug policy, inspecting pharmacies and factories, issuing import and export permits for medicines, pharmaceuticals, nutritional supplements and therapeutic cosmetics, and overseeing the registration of pharmaceutical companies and their products. Its sections include Registration and Drug Pricing, Drug Quality Control Laboratory, Inspection and Narcotics, and Drug Release.

We quote that remit because it frames the Qatari starting point: a company in Qatar is used to a ministry that registers companies and products together. We have not found a device-specific registration procedure described on the ministry's site, and we do not describe one here. For the Union side it does not matter. Whatever approval a Qatari company holds at home, Regulation (EU) 2017/745 does not recognise it, and the European file starts from zero.

Brand owners in Qatar: the Regulation has a name for that role

A company in Doha that has a product designed and made by a factory elsewhere and sells it under its own name is not a distributor in the eyes of the Regulation. It is the manufacturer:

"‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;"

Regulation (EU) 2017/745, Article 2(30).

That status brings Article 10 with it: quality management system, technical documentation, declaration of conformity, post-market surveillance, vigilance. It also brings Article 11(1), because a company established in Qatar is not established in a Member State:

"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 alternative is to stay out of the manufacturer role entirely by having the factory named as manufacturer on the label. Article 16(1)(a) sets the condition under which a person selling under its own name does not assume the manufacturer's obligations:

"makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;"

Regulation (EU) 2017/745, Article 16(1)(a).

Both routes work. Which one you take decides who needs the representative, whose SRN goes in EUDAMED and whose name goes on the label. We ask this question first in every Gulf file; the roles are set side by side in authorized representative vs importer vs PRRC.

Why a representative in Türkiye is a Union representative

"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.

Medex is established in Ankara and holds EUDAMED authorized representative single registration number TR-AR-000057550. One mandate covers the Union and Türkiye for the generic device group it names. If the devices are also sold in Türkiye, the Turkish importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, which we handle for importers under a separate contract.

Documents from Qatar

PointPosition
Apostille ConventionQatar does not appear in the HCCH status table of Contracting Parties. A Qatari public document is certified abroad by consular legalisation, not by Apostille.
MandateNo legalisation is required by MDR. The mandate is effective when accepted in writing by the representative (Article 11(2)).
Declaration of conformity and technical documentationPrivate documents of the manufacturer; no legalisation. Kept by the representative under Article 11(3)(b) for the period in Article 10(8).
LanguageThe ministry publishes in Arabic and English. The Union file is answered in a Union language under Article 11(3)(d); English is the practical choice for the declaration and the core documentation.
Turkish sideA Qatari corporate document used before a Turkish authority is legalised through the consular route and accompanied by a sworn Turkish translation.

How long we keep your file

"Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market."

Regulation (EU) 2017/745, Article 10(8), first sentence.

Article 11(3)(b) ties the representative to the same period. That is the practical meaning of the three-year fixed fee on our pricing page: the relationship is designed to last as long as the devices and their documentation do. What the fee covers is set out under authorized representative cost.

The person responsible for regulatory compliance on our side

"Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union."

Regulation (EU) 2017/745, Article 15(6), first sentence.

A representative without that person is not compliant, whatever its address. Ours is in place and named in the mandate.

Medex is an authorized representative under Article 11 and nothing else in the chain. We are not a notified body: a notified body is, in the words of Article 2(42), "‘notified body’ means a conformity assessment body designated in accordance with this Regulation;" and only such a body can issue the certificate a class IIa, IIb or III device needs. We are not your importer or distributor either; the importer is the Union entity that physically places your consignment on the market, and that role carries its own duties under Article 13.

Fees are listed on our pricing page: "Fees from EUR 800 a year, no setup fee, one mandate." and "Fees are in euros, exclude VAT, and are fixed for three years from signature."

Gulf pages: United Arab Emirates, Saudi Arabia and Kuwait.

Frequently asked questions

Our company in Doha owns the brand but a factory abroad makes the device. Who needs the authorized representative?

Whoever is the manufacturer under Article 2(30), which is the entity marketing the device under its name or trademark. If that is your Qatari company, it needs the representative under Article 11(1). If the factory is identified as manufacturer on the label and takes on the Article 10 obligations under an agreement, as Article 16(1)(a) describes, the factory needs the representative if it is outside the Union.

Qatar is not a party to the Apostille Convention. Does that delay the mandate?

No. The mandate needs written acceptance by the representative, not legalisation. Consular legalisation is relevant only where a Qatari public document is presented to a national authority, for example in Türkiye.

Does a Qatari ministry approval help with CE marking?

No. Regulation (EU) 2017/745 does not recognise approvals from outside the Union. Conformity is shown through technical documentation and, above class I, a notified body certificate.

Can one mandate cover both the European Union and Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement. One mandate with a representative established in Türkiye covers both for the generic device group it names.

What does Medex not do?

Medex is not a notified body and issues no certificates; it is not your importer or distributor; it does not find distributors for you; and it does not draft your technical documentation inside the representative fee, which the pricing page lists as excluded.

Tell us who is named on the label today, where the device is made and in which class you believe it falls, and we will tell you which entity is the manufacturer and what the mandate will cover. Request a proposal.

Sources and further reading

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