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EU Authorized Representative for Bosnia and Herzegovina Manufacturers

Bosnia and Herzegovina is not a Member State of the European Union. Medical devices there fall under the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, established by the Act on Medicinal Products and Medical Devices published in Official Gazette of B-H No. 58/08 and operating since 1 May 2009. A manufacturer in Sarajevo, Banja Luka or Mostar that sells into the Union is a third-country manufacturer under Regulation (EU) 2017/745. This page explains what the Agency's registers do, why they stop at the Union border, and how the Article 11 mandate is set up.

ALMBIH and the state-level Act

The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBIH) states that it was established by the Act on Medicinal Products and Medical Devices, Official Gazette of B-H No. 58/08, as the authority for medicinal products and medical devices used in medical practice in Bosnia and Herzegovina, and that it started work on 1 May 2009. Its regulations page lists, under legislation at the state level, the Medicinal Products and Medical Devices Act and an Ordinance on Medical Devices among the implementing ordinances. The Agency also maintains a Registry of manufacturers of medicinal products and medical devices in Bosnia and Herzegovina, and runs pharmacovigilance and materiovigilance.

A manufacturer in Bosnia and Herzegovina therefore holds an entry in a state-level register and, for its devices, whatever registration the Ordinance on Medical Devices requires. Both are instruments of the domestic market.

Outside the Union, the certificate underneath is what counts

Regulation (EU) 2017/745 does not apply in Bosnia and Herzegovina, and ALMBIH is not a Union competent authority. An ALMBIH registration is not an EU declaration of conformity and not a certificate under Article 56. Conformity for the Union market is established under the Regulation only:

"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)

Where a manufacturer in Bosnia and Herzegovina already holds a CE certificate from a notified body designated under the Regulation, the Union work that remains is the economic operator chain: the sole representative, the EUDAMED actor registration and the device registration. Where it does not, the route begins with the conformity assessment itself.

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 Union defines the role narrowly:

"‘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)

A company established in Bosnia and Herzegovina cannot hold the Union mandate. MDCG 2022-16 adds that a manufacturer may use different representatives for different generic device groups, but for one specific group should designate only one.

Why Medex, in Türkiye, can be the representative

Medex acts under EUDAMED SRN TR-AR-000057550 from Ankara and İstanbul, with a further office in Gdańsk. The EU-Türkiye Customs Union extends the Union market for medical devices to Türkiye, as MDCG 2022-16 records:

"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 states 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. A manufacturer in Bosnia and Herzegovina with Medex as representative 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 carries out.

Documents, language and the apostille

Files from Bosnia and Herzegovina are in Bosnian, Croatian or Serbian. Croatian is an official Union language, so a competent authority that determines Croatian can be answered with a Croatian file. For other Member States Medex asks for the EU declaration of conformity and the core technical documents in English:

"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 (Article 19(1)), and labels and instructions for use follow Article 10(11). On legalisation, the HCCH status table lists Bosnia and Herzegovina as a Contracting Party to the Hague Apostille Convention by succession, with entry into force recorded as 6 March 1992. The Regulation does not require the mandate to be apostilled. For ÜTS filings in Türkiye, TİTCK's guide TCKKD-KLVZ-03, Article 8, requires an apostilled original of a foreign certificate, with the apostille from the manufacturer's country or from the country of the EU Authorized Representative, or a Turkish consular attestation, or a verifiable e-signed original, with a sworn Turkish translation.

Positions compared

Bosnia and Herzegovina (Act, OG B-H 58/08)Union (Regulation (EU) 2017/745)Carries across?
ALMBIH as state-level authority since 1 May 2009Competent authority of the Member State where the representative is established (Article 11(7))Structure differs
Registry of manufacturers of medicinal products and medical devicesEUDAMED actor registration with SRN (Article 31)No
Device registration under the Ordinance on Medical DevicesEU declaration of conformity (Article 19) and certificate (Article 56)No
Materiovigilance reporting to ALMBIHVigilance under Articles 87 and 88; the representative is informed under Article 11(3)(g)Separate systems
Bosnian, Croatian or Serbian documentationLanguage determined by each Member State's authority; label per Article 10(11)Croatian usable where determined; otherwise translation

Mandate and EUDAMED

"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)

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 obtains its own SRN, through the EUDAMED registration service if needed, and Medex verifies the device registrations under Articles 27 and 29. 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

Our devices are registered with ALMBIH on the basis of a CE certificate. What remains for the Union?

The Union side of the operator chain: a sole representative under Article 11, EUDAMED actor registration under Article 31, device registration with Basic UDI-DI under Articles 27 and 29, and the representative's name on the label under Annex I, Section 23.2(d).

Does anything short of EU membership give our devices status in the Union?

No. The Regulation applies in the Member States and, through the EEA and the Customs Union, in Norway, Iceland, Liechtenstein and Türkiye. A manufacturer in Bosnia and Herzegovina is a third-country manufacturer under Article 11(1).

Can our Croatian-language file be used as it is?

For an authority that determines Croatian, yes. For others Medex needs the EU declaration of conformity and the core documents in a language that authority determines, usually English.

Is an apostille needed on the mandate?

Not under the Regulation. An apostille is needed only for documents uploaded to ÜTS in Türkiye; the HCCH table records the Apostille Convention in force for Bosnia and Herzegovina by succession from 6 March 1992.

Who registers the devices in EUDAMED?

The manufacturer, with its own SRN and Basic UDI-DI; Article 11(4) prevents that duty from being delegated. Medex registers as representative, links the mandate and verifies under Article 11(3)(c) that the manufacturer has registered.

Sources and further reading

To appoint an EU Authorized Representative for devices made in Bosnia and Herzegovina, 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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