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EU Authorized Representative for Kazakhstan: From National Expertise to MDR Conformity

Kazakhstan registers medical devices through expert evaluation at the National Center for Expertise of Medicines and Medical Devices. The Center's own vocabulary separates medical products, medical equipment and in vitro diagnostics; Regulation (EU) 2017/745 uses one definition and one set of classification rules, and recognises no Kazakh registration as proof of conformity. This page explains what changes for a Kazakh manufacturer at the Union border, what Article 11(1) demands, and how a single mandate with a representative in Türkiye covers the Union market and Türkiye together.

Three Kazakh terms, one European definition

The expert body in Kazakhstan is the National Center for Expertise of Medicines and Medical Devices, a state enterprise publishing at ndda.kz. Its medical devices page splits the field into three groups: medical devices in the broad sense, then "izdeliya meditsinskogo naznacheniya" (materials, articles, solutions, reagents, kits and sets used in medical care), "meditsinskaya tekhnika" (apparatus, instruments, equipment, complexes and systems with a functional purpose and operating characteristics set by the manufacturer), and in vitro diagnostic devices.

Regulation (EU) 2017/745 does not use that division. A single definition in Article 2(1) covers instruments, apparatus, software, implants, reagents and materials alike, and in vitro diagnostics sit in a separate regulation, (EU) 2017/746. The first task in a Kazakh file is therefore a translation of categories, not of language: a product the Center treated as medical equipment and a product it treated as a medical product may land in the same MDR class, or in different ones, depending on Annex VIII and not on the Kazakh label.

Expertise is not conformity assessment

The word in the Center's name matters. The Center carries out expert evaluation for state registration in Kazakhstan. In the Union the act that leads to a CE marking above class I is conformity assessment by a notified body:

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

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

A positive expert conclusion from the Center is a national decision. It is not a certificate under Article 56 and no notified body is bound by it. Where a Kazakh file contains electrical safety, electromagnetic compatibility or biocompatibility reports against the relevant standards, those reports are reusable evidence inside the MDR technical documentation. The registration certificate is not. The three Union roles are compared in authorized representative, importer and PRRC.

The condition in Article 11(1), and the Customs Union answer

"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).

A manufacturer in Almaty, Astana or Shymkent is not established in a Member State. Before the first unit is placed on the Union market, a sole representative must have accepted a written mandate. Medex is established in Türkiye, and MDCG 2022-16 explains why that satisfies the requirement:

"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 consequence for a Kazakh exporter that ships westwards through Türkiye is practical: the Turkish market and the Union market are covered by the same representative, under the same mandate, for the same generic device group. If a Turkish importer also sells the devices in Türkiye, that importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, under a separate contract with us. Nothing in the Union mandate pays for or replaces that registration.

What the mandate must contain

Article 11(3) lists the minimum tasks. Two of them shape the working relationship with a manufacturer whose records are kept in Russian or Kazakh.

"keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);"

Regulation (EU) 2017/745, Article 11(3)(b).

"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).

Point (b) means we hold your technical documentation and declaration of conformity, not a summary of them. Point (d) means that when a German or Italian competent authority asks, the answer goes back in a Union language the authority has determined. Keeping the declaration of conformity, labels, instructions for use and the core of the technical file in English from the start is what makes point (d) workable.

Paperwork between Kazakhstan, Türkiye and the Union

ItemKazakh position
Apostille ConventionKazakhstan is a Contracting Party. The HCCH status table records accession on 5-IV-2000 and entry into force on 30-I-2001.
MandateValid when accepted in writing by the representative (Article 11(2)). No Apostille is required by MDR for the mandate.
Türkiye sideWhere a Kazakh document is used before a Turkish authority, for example in a Turkish importer's ÜTS file, an Apostille issued in Kazakhstan is accepted under the Convention and a sworn Turkish translation is added.
LabelAnnex I, Section 23.2(d): the label of a device whose manufacturer is outside the Union carries the name and registered place of business of the authorized representative.
EUDAMEDManufacturer and representative each hold a single registration number. Medex holds TR-AR-000057550; see EUDAMED registration. The manufacturer's SRN is issued after the competent authority verifies the data (Article 31(2)).

Liability, and why we read the file before accepting the 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).

That paragraph is the reason an authorized representative is not a letterbox. If the manufacturer has not met Article 10, the representative stands jointly and severally liable for defective devices. We therefore verify, before signing, that the EU declaration of conformity and technical documentation exist and that the conformity assessment route matches the class. For a class I device that is a documentation check. For a class IIa device and above it includes the notified body certificate.

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."

Related country pages: Uzbekistan, Georgia and Türkiye.

Frequently asked questions

Our registration certificate from the National Center of Expertise lists the device as medical equipment. Is that its MDR class?

No. The Kazakh grouping into medical products, medical equipment and IVDs is a national taxonomy. The MDR class comes from the rules in Annex VIII and is set by intended purpose, duration of contact and other criteria, not by the Kazakh category.

Is the Center a notified body?

No. A notified body is a conformity assessment body designated under the Regulation by a Member State. The Center is a Kazakh expert body for national registration.

We ship to Europe via Türkiye. Do we need two representatives?

No. MDCG 2022-16 confirms that the Union market extends to Türkiye through the Customs Union Agreement, so one representative established in Türkiye covers both, for the generic device group named in the mandate.

Our technical file is in Russian. Is that a problem?

For the mandate, no. For Article 11(3)(d), yes: the representative has to provide information demonstrating conformity in an official Union language determined by the Member State concerned. The declaration of conformity and the core of the file should be in English before the devices are placed on the market.

Does an Apostille from Kazakhstan work in Türkiye?

Yes. Both states are Contracting Parties to the Apostille Convention, so a Kazakh public document with an Apostille is accepted in Türkiye without consular legalisation. A sworn Turkish translation is then added for Turkish authorities.

Send us your Kazakh registration certificates and the product list with intended purpose, and we will return the MDR class per device and the mandate draft. Request a proposal.

Sources and further reading

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