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EU Authorized Representative for Uzbekistan: National Certification and the MDR Mandate

Uzbekistan certifies medical products and medical equipment through a national scheme run by the Center for Pharmaceutical Product Safety, created in July 2023 under the Ministry of Health. That certificate is a national act, and the Union does not read it. An Uzbek manufacturer that wants its own name on a device sold in the European Union needs a sole authorized representative under Article 11(1) of Regulation (EU) 2017/745, an EUDAMED registration and documentation in a Union language. This page covers those steps, the Apostille position (Uzbekistan is a party, but several EU states have objected), and why one mandate with Medex in Türkiye covers the Union and Türkiye at once.

A new authority, a certification system, and where the Union stands

Uzbekistan reorganised its regulator recently. The Center for Pharmaceutical Product Safety under the Ministry of Health (uzpharm-control.uz) states on its own site that it was created by Resolution of the President No. PP-197 of 20 July 2023, and lists its tasks: state registration, standardisation, certification and technical regulation of medicines, medical products and medical equipment; drafting the legal acts in that field; and coordinating and supervising the certification bodies and testing laboratories for those products as the central certification body.

Two of those words, certification and technical regulation, sound close to the European system and are not. Certification in Uzbekistan is issued inside a national scheme run by the Center and the bodies it coordinates. In the Union, a certificate for a device above class I is issued by a notified body under Annex IX, X or XI of Regulation (EU) 2017/745, and a notified body is defined narrowly:

"‘notified body’ means a conformity assessment body designated in accordance with this Regulation;"

Regulation (EU) 2017/745, Article 2(42).

No Uzbek certification body is designated under the Regulation. An Uzbek certificate of conformity therefore proves nothing to a European competent authority, whatever standards it cites. What can be reused is the test data behind it, where the tests were run to the standards the technical documentation relies on.

Who the manufacturer is, in Tashkent and in the Regulation

"‘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).

The definition turns on the name on the device. An Uzbek company that has its disposable products made by a contract factory and sells them under its own brand is the manufacturer under Article 2(30) and carries the obligations of Article 10 in full. The same company then meets Article 11(1):

"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).

One mandate, two markets: the Customs Union footnote

Medex is established in Ankara. The reason a representative in Türkiye counts for the whole Union market is set out by the Medical Device Coordination Group:

"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.

For an Uzbek manufacturer the point is not academic. Goods bound for Europe through Türkiye enter a territory where the same mandate and the same representative apply. If the devices are also sold in Türkiye, the Turkish importer must register them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system; that is a Turkish obligation on the importer and a separate piece of work, described under Türkiye market access.

Apostille: Uzbekistan is a party, with objections on record

The HCCH status table lists Uzbekistan as a Contracting Party to the Apostille Convention, accession 25-VII-2011 and entry into force 15-IV-2012, but marks the accession with the objection code. The notifications page records objections from Germany, Austria and Greece, and records that Belgium, which had also objected, withdrew its objection with effect from 11 June 2025. Where a state has objected, the Convention is not in force between that state and Uzbekistan, and an Uzbek Apostille is not accepted there. Türkiye is not among the objecting states.

Use of the documentWhat applies
Mandate under Article 11No Apostille is required by MDR. The mandate is effective when accepted in writing by the representative (Article 11(2)).
Uzbek corporate or signatory document used in TürkiyeApostille issued in Uzbekistan, plus a sworn Turkish translation. The Convention is in force between Uzbekistan and Türkiye.
Same document used before an authority in Germany, Austria or GreeceApostille not accepted; consular legalisation route applies, because those states have objected to Uzbekistan's accession.
Language of the Union fileThe Center publishes in Uzbek and Russian. Article 11(3)(d) requires answers to a competent authority in an official Union language, so the declaration of conformity and core documentation must be in English or another Union language.

Registration: your SRN, our SRN, and the two-year confirmation

Both the manufacturer and the representative register in EUDAMED and receive a single registration number. Medex holds TR-AR-000057550 as authorized representative. Your number is issued after verification:

"After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer."

Regulation (EU) 2017/745, Article 31(2).

Registration is not a one-off. The data must be confirmed on a fixed cycle:

"Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation."

Regulation (EU) 2017/745, Article 31(5).

We track that cycle for our own record and remind you of yours; the steps are described under EUDAMED registration. The mandate record in EUDAMED links the two SRNs, and the devices registered under your Basic UDI-DIs sit beneath that link.

What is not delegated

"Whilst the manufacturer therefore can not delegate its responsibility for these tasks, the authorised representative is not prevented from assisting in the performance of those tasks."

MDCG 2022-16, section 4.

Article 11(4) keeps the quality management system, the technical documentation, the declaration of conformity, post-market surveillance and vigilance with the manufacturer. We can assist with those tasks, and for technical documentation we do, but the obligation and the signature remain yours.

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."

See also Kazakhstan, Pakistan and Türkiye.

Frequently asked questions

Our products carry an Uzbek certificate of conformity. Is that recognised in the EU?

No. The certificate is issued within a national scheme coordinated by the Center for Pharmaceutical Product Safety. Only a notified body designated under Regulation (EU) 2017/745 can issue the certificate a class IIa, IIb or III device needs in the Union.

Uzbekistan joined the Apostille Convention. Why do some EU states refuse an Uzbek Apostille?

Because Germany, Austria and Greece lodged objections to Uzbekistan's accession, recorded in the HCCH status table. The Convention is not in force between Uzbekistan and those states. Belgium withdrew its objection with effect from 11 June 2025. Türkiye did not object.

Does the mandate itself need an Apostille?

No. Under Article 11(2) the designation is valid when accepted in writing by the authorized representative. An Apostille becomes relevant only where an Uzbek public document is relied on before a national authority, for example in Türkiye.

We outsource production to a contract factory. Who is the manufacturer?

The company that markets the device under its name or trademark, under Article 2(30). If that is your Uzbek company, you carry Article 10 and need the representative under Article 11(1).

Can Medex write our technical documentation?

We provide technical documentation support, and the pricing page lists drafting technical documentation as outside the annual representative fee. The obligation to hold a complete file remains the manufacturer's under Article 10, which Article 11(4) does not allow the mandate to delegate.

Send us the product list with intended purpose, the Uzbek certificates you hold and the name that appears on the label, and we will tell you which entity is the manufacturer, what class each device is and what the mandate will cover. Request a proposal.

Sources and further reading

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