EU Authorized Representative for Serbia: From ALIMS Registration to MDR Market Access

Serbia's Law on Medical Devices still speaks the language of the Directives

The Law on Medical Devices was published in the Official Gazette of the Republic of Serbia No. 105 of 23 November 2017. It replaced the medical device provisions of the earlier Law on Medicines and Medical Devices. Its concepts are European, but they are the concepts of the Directive era. Article 2 defines a notified body as a body notified to the European Commission "за обављање поступака оцењивања усаглашености медицинског средства са захтевима директива Европске уније" [for carrying out conformity assessment procedures for medical devices against the requirements of European Union directives]. Conformity is measured against основни захтеви, essential requirements, the Directive term that MDR replaced with general safety and performance requirements.

Article 24 sorts general medical devices into four classes: I, IIa, IIb and III. Under MDR, those classes survive by name, but the rules behind them do not. Annex VIII of Regulation (EU) 2017/745 contains twenty-two classification rules against the Directive's eighteen, and the sub-classes Is, Im and Ir change what a notified body must audit. A Serbian class I device that is sterile, measures, or is a reusable surgical instrument needs notified body involvement for those aspects:

"If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." (MDR Article 52(7))

ALIMS recognises the CE marking; the Union does not recognise the Serbian mark

Article 17 of the Serbian law allows a device onto the market only with one of two marks: "Медицинско средство може да буде стављено на тржиште, односно у употребу само ако је обележено СЕ знаком или српским знаком усаглашености" [A medical device may be placed on the market or put into service only if it bears the CE mark or the Serbian mark of conformity]. Article 16 then provides that ALIMS recognises foreign conformity documents and the CE mark in the registration procedure.

The Serbian mark is issued on the basis of conformity assessment by a Serbian body. Under Article 26, a conformity assessment body established in Serbia must be accredited by the Accreditation Body of Serbia and designated by the minister. Under Article 15, a manufacturer that needs a third-party body may choose either a notified body in the EEA or a mutual recognition country, or a body designated in Serbia.

That choice has a consequence the law does not spell out. A Serbian designated body can support the Serbian mark. It cannot support the CE marking, because only a notified body designated under MDR can issue an MDR certificate. The recognition is one-directional: ALIMS accepts the CE marking, and the Union has no mechanism that accepts the Serbian mark.

A Serbian registration depends on the validity of the conformity document

Article 50 of the law requires ALIMS to register devices in the Register of Medical Devices. Article 52 then links the registration's life to the conformity evidence behind it: "О регистрацији медицинског средства Агенција издаје решење на рок важности од 60 дана након истека важности исправе о усаглашености." [The Agency issues the registration decision with a validity ending 60 days after the conformity document expires.] For class I devices placed on the market on the manufacturer's own declaration of conformity, the decision is issued for five years.

The design is sensible for a regulator that relies on foreign certificates, and it tells a Serbian manufacturer something useful. Article 52 also allows devices to remain on the market for at most 90 days after a registration decision expires, and bars import of a device whose registration has lapsed without a timely renewal application, so certificate renewals and registration renewals have to be planned together. Its Serbian registration is only as good as the certificate or declaration behind it. If that document is Serbian, it does not travel. If it is an MDR certificate from a notified body, it supports both the Serbian registration and the CE marking.

Serbia already makes foreign manufacturers appoint a representative in Serbia

Article 2 defines the authorised representative of a foreign manufacturer as a legal or natural person established in Serbia, authorised in writing, and "одговорно за сигурност и перформансе одређеног медицинског средства на исти начин као и произвођач тог медицинског средства" [responsible for the safety and performance of the device in the same way as the manufacturer of that device]. Under Article 51, only a Serbian manufacturer, a Serbian branch or office of a foreign manufacturer, or that authorised representative may apply for registration.

MDR applies the mirror rule to a Serbian manufacturer exporting to the Union:

"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." (MDR Article 11(1))

The allocation of liability will be familiar. Serbian law makes the representative responsible in the same way as the manufacturer. MDR provides that where a manufacturer outside the Union has not complied with Article 10, the representative is liable for defective devices jointly and severally with it (Article 11(5)). Serious representatives therefore verify before they sign.

Candidate since 2012, still a third country for MDR purposes

The European Commission records that Serbia was granted candidate status in March 2012, that its Stabilisation and Association Agreement entered into force in September 2013, and that accession negotiations formally began at the first intergovernmental conference on 21 January 2014. Candidate status does not change a Serbian manufacturer's position under MDR. Until accession, Serbia is a third country, and Article 11 applies to every device placed on the Union market under a Serbian manufacturer's name.

Getting the Union side in place from Belgrade, Novi Sad or Niš

Medex Kurumsal Danışmanlık is established in Türkiye. Under the EU–Türkiye Customs Union, the European Commission's March 2022 Notice to Stakeholders states that 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." Medex holds EUDAMED authorised representative SRN TR-AR-000057550. Switzerland and Great Britain require representatives established there (CH-REP and UKRP); Medex does not act in those roles or for the EEA-EFTA states.

The sequence for a Serbian manufacturer:

1. Mandate under Article 11(3). A written mandate covering at least all devices of the same generic device group. It must include the statutory tasks:

"The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;" (MDR Article 11(3))

2. Verification. Medex checks the EU declaration of conformity, the technical documentation and, where applicable, the notified body certificate. Medex does not write technical documentation, is not a notified body and does not find distributors.

3. EUDAMED actor registration. The manufacturer registers as an actor and obtains its SRN; the mandate is recorded in EUDAMED against Medex's SRN.

4. Basic UDI-DI and UDI. Basic UDI-DIs per device group and UDI-DIs down to packaging level, with the Annex VI core data, which Medex verifies under Article 11(3)(c).

5. PRRC. Medex has an in-house person responsible for regulatory compliance, as Article 15(6) requires.

6. Label and IFU. Annex I, Section 23.2(d) requires the representative's name and registered address on the label.

Published annual fees run from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative. See the pricing page for the full table.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for Türkiye, Ukraine and Egypt. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

Our devices are registered with ALIMS. Does that help in the Union?

Not for conformity. An ALIMS registration confirms that a device may be placed on the Serbian market; it is not evidence that the device meets MDR Annex I. If the registration rests on a Serbian designated body's certificate, that certificate cannot support a CE marking. The test reports and validations behind it remain reusable evidence.

We hold a CE certificate from a notified body. Do we still need an authorised representative?

Yes, if you are the legal manufacturer and established in Serbia. The certificate proves conformity; Article 11(1) is a separate condition for placing devices on the Union market. The representative also has its own registration duties and must verify your UDI and device registration under Article 11(3)(c).

Can our Serbian authorised representative for a foreign brand act as that brand's EU representative?

No. An authorised representative under MDR Article 11 must be established in a Member State, or in Türkiye under the Customs Union arrangement. A company established in Serbia cannot hold that mandate before accession.

We manufacture under a Western European customer's brand. Do we need a representative?

Not for those products. If the customer is named on the label as manufacturer and is established in a Member State, it carries Article 10 and needs no representative. Products you sell under your own name need their own mandate.

Sources

Law on Medical Devices, Official Gazette of the Republic of Serbia No. 105/2017 (ALIMS) — www.alims.gov.rs

ALIMS, Laws (regulations page) — www.alims.gov.rs

European Commission, Enlargement and Eastern Neighbourhood: Serbia — enlargement.ec.europa.eu

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.

Other countries we cover

We act as EU authorized representative for manufacturers in many markets. See the pages for Ukraine, the United Kingdom, Switzerland, the United States, China and India, or browse the full list by country and the list by device category.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.