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EU Authorized Representative for North Macedonian Device Manufacturers

North Macedonia is not a Member State of the European Union. Medical devices there are overseen by the Agency for Medicines and Medical Devices, MALMED, founded on 16 September 2014 under the Law on Medicines and Medical Devices as an independent body of the state administration, with a register of medical devices and classes that follow the former Union Directives. A manufacturer in Skopje that sells into the Union is a third-country manufacturer under Regulation (EU) 2017/745 and must designate a sole representative established in the Union. This page explains both halves.

MALMED and the Law on Medicines and Medical Devices

The Agency for Medicines and Medical Devices (MALMED) states that it was founded on 16 September 2014 on the basis of the Law on Medicines and Medical Devices (Official Gazette of RM No. 106/07 and subsequent amendments) as an independent body of the state administration, with the Government as its founder. Its medical devices page classifies devices by risk into Class I, Class IIa, Class IIb and Class III, and in vitro diagnostic devices into those used only by professionals and classified in lists A and B, self-testing devices and all other IVDs. Devices are entered in a register of medical devices, which also governs where they may be dispensed.

The vocabulary is that of the former Union Directives, and the register is a national one. A MALMED entry tells a European distributor nothing it can act on.

Outside the Union, the certificate underneath is what counts

Regulation (EU) 2017/745 does not apply in North Macedonia, and MALMED is not a Union competent authority. The Union establishes conformity 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)

A manufacturer whose MALMED registration already rests on a CE certificate from a notified body designated under the Regulation has done most of the Union work; what remains is the operator chain of representative, EUDAMED actor registration and device registration. A manufacturer whose registration rests on something else starts with the conformity assessment. The lists A and B used for IVDs in North Macedonia have no counterpart in Regulation (EU) 2017/746, which classifies IVDs into Classes A to D under its own Annex VIII; the IVDR classification tool gives a first reading.

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 same sentence appears in Article 11(1) of the IVD Regulation:

"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) 2017/746, Article 11(1)

The representative must be established within the Union, must accept the mandate in writing and is the only representative for a given generic device group. A company established in North Macedonia cannot hold the role.

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, which MDCG 2022-16 records 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, footnote 1

The European Commission's Notice to Stakeholders of March 2022 concludes:

"manufacturers established outside the territory of the EU or Turkey only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey."

European Commission, Notice to Stakeholders: EU-Türkiye Customs Union Agreement in the field of medical devices (March 2022), Section I.2

A North Macedonian manufacturer with Medex as representative therefore 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.

Macedonian documents, translation and the apostille

Files from North Macedonia are in Macedonian, which is not an official Union language. Medex asks manufacturers for the EU declaration of conformity and the core technical documents in English, because the representative must answer competent authorities in the language they determine:

"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 North Macedonia as a Contracting Party to the Hague Apostille Convention by succession, with entry into force recorded as 17 November 1991. 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

North Macedonia (MALMED)Union (Regulations (EU) 2017/745 and 2017/746)Carries across?
Register of medical devicesEUDAMED device registration (Article 29 MDR)No
Classes I, IIa, IIb, IIIClasses I, IIa, IIb, III under MDR Annex VIIISame labels; class re-derived
IVD lists A and B, self-testing, otherIVDR Classes A to D under its Annex VIIIDifferent scheme; re-classify
Dispensing rules tied to the registerNot a Union matter; national rules on distribution apply per Member StateNot applicable
Macedonian documentationLanguage determined by each Member State's authority; label per Article 10(11)Translation needed

Mandate and EUDAMED

"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)

Medex drafts the mandate to the tasks of Article 11(3), accepts it in writing, registers as an actor under Article 31 and verifies the manufacturer's registrations under Articles 27 and 29. A manufacturer without a single registration number starts with the EUDAMED registration service. 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 in the MALMED register on the strength of a CE certificate. What is left 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).

Our IVD is on list B in North Macedonia. What class is it under the IVDR?

The IVDR classifies IVDs into Classes A to D under its own Annex VIII rules, which do not use lists A and B. The class is derived from the intended purpose; the IVDR classification tool on this site gives a first reading and Medex confirms it against the rules.

Can a company in Skopje be our EU representative?

No. Article 2(32) requires the representative to be established within the Union, and the Customs Union extends that to Türkiye. A North Macedonian company cannot hold the mandate.

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 North Macedonia by succession from 17 November 1991.

Does one mandate cover the EU and Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement, and the Commission's Notice to Stakeholders states that a third-country manufacturer needs one representative, in either territory, for both. ÜTS device registration in Türkiye is a separate step.

Sources and further reading

To appoint an EU Authorized Representative for devices made in North Macedonia, 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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