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EU Authorized Representative for Georgia: From Tbilisi Registration to MDR Article 11

A device registered in Georgia is registered for Georgia. The State Regulation Agency for Medical and Pharmaceutical Activities in Tbilisi issues permits, keeps registers and inspects establishments, and none of that output is read by a European competent authority as proof of conformity with Regulation (EU) 2017/745. This page sets out what a Georgian manufacturer must put in place on the Union side, starting with the sole authorized representative required by Article 11(1), and why a representative established in Türkiye covers both the Union and the Turkish market under one mandate.

What the Tbilisi agency regulates, and what it cannot do for Europe

Georgia's national regulator for medicines and medical activity is the State Regulation Agency for Medical and Pharmaceutical Activities, a legal entity of public law whose site sits under the health ministry's domain at rama.moh.gov.ge. The agency's site is in Georgian. Its published structure lists, among its units, a registration division for diagnostic test systems and dental materials, a departmental register of pharmaceutical products, and licensing and permit functions for pharmaceutical establishments. For a Georgian manufacturer this is the authority whose file you already know.

None of that file travels. Regulation (EU) 2017/745 contains no mechanism by which a registration, permit or inspection act issued in Georgia is recognised as evidence of conformity with Annex I. The Union side starts from the general safety and performance requirements, the technical documentation in Annex II and III, and the conformity assessment route for the class of the device. Georgian test reports and quality records can be reused as evidence inside that file; the Georgian approval itself cannot.

Article 11(1): the sentence that applies to every Georgian manufacturer

"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).

Georgia is not a Member State, so the condition is met the moment a device made in Georgia is placed on the Union market under a Georgian manufacturer's name. The representative must be a legal person established within the Union, defined in Article 2(32) as follows.

"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;"

Regulation (EU) 2017/745, Article 2(32).

Why a representative in Türkiye counts as a Union representative

Medex Kurumsal Danışmanlık is established in Ankara. The reason a Turkish company can hold the Article 11 mandate is written into the Commission's guidance on authorized representatives, MDCG 2022-16, 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, Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746, footnote 1.

The same document sets out how many representatives a manufacturer may have:

"However, for one specific generic device group, the manufacturer should designate only one authorised representative (i.e. a ‘sole’ authorised representative’)."

MDCG 2022-16, section 4, Designation and mandate.

In practice this means one mandate with Medex covers the Union market and Türkiye for the generic device group it names. A Georgian manufacturer that sells through Türkiye and into the Union does not need a second representative for the Turkish side. Where the devices are also sold in Türkiye, the Turkish importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system; that work is a separate contract under Türkiye market access.

Documents from Georgia: Apostille, language, format

PointPosition for a Georgian manufacturer
Apostille ConventionGeorgia is a Contracting Party. The HCCH status table records accession on 21-VIII-2006 and entry into force on 14-V-2007, with no objection code.
What MDR asks forMDR does not require the mandate to be apostilled. The mandate is valid, under Article 11(2), when accepted in writing by the representative.
Where an Apostille is still usedWhere a Georgian corporate or signatory document is to be relied on in Türkiye, for example in ÜTS registration by a Turkish importer, an Apostille from Georgia is the simple route.
LanguageThe agency publishes in Georgian. Article 11(3)(d) requires the representative to answer a competent authority in an official Union language, so the declaration of conformity and the documents behind it must exist in English or another Union language.

"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).

Mandate and EUDAMED, step by step

  • You send the list of devices with Basic UDI-DI, class and conformity assessment route. We check that the devices fall into the generic device group the mandate will name.
  • We draft the mandate on the basis of Article 11(3)(a) to (h). You sign; we accept in writing. That acceptance is what makes the designation effective.
  • We register your mandate against our EUDAMED actor record. Medex holds the authorized representative single registration number TR-AR-000057550.
  • You register as a manufacturer in EUDAMED and receive your own SRN. The number is issued by the competent authority after it has verified your data:

"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).

  • Your label and instructions for use carry our name and registered place of business, as Annex I, Section 23.2(d) requires for a manufacturer established outside the Union.
  • We keep the technical documentation and the EU declaration of conformity available to competent authorities for the period in Article 10(8).

What Medex is, and is not, in a Georgian project

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."

Neighbouring files: Türkiye, Kazakhstan and Ukraine.

Frequently asked questions

Our devices are registered with the Georgian agency. Do we still need an authorized representative?

Yes. Georgian registration has no effect in the Union. Article 11(1) requires a sole authorized representative for any manufacturer not established in a Member State, and Georgia is not one.

Can one mandate cover the European Union and Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement. A single mandate with a representative established in Türkiye covers both.

Do our Georgian documents need an Apostille for the mandate?

Not for the mandate itself; MDR asks only for written acceptance. Georgia is a Contracting Party to the Apostille Convention, so where an Apostille is needed for other purposes, for example in Türkiye, it is available.

Can our Georgian test reports be used in the technical documentation?

They can be used as evidence if they were generated against the standards the technical documentation relies on. The Georgian registration decision itself is not evidence of MDR conformity.

Does Medex carry out the conformity assessment for a class IIa device?

No. Conformity assessment above class I is performed by a notified body, which is a conformity assessment body designated under the Regulation. Medex is an authorized representative and holds and verifies the documentation; it does not certify.

Send us the device list with class and Basic UDI-DI and the Georgian registration references, and we will return the mandate draft and the EUDAMED sequence for your file. Request a proposal.

Sources and further reading

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