Croatia medical device regulatory resources

Competent authorities — Ministry of Health and HALMED

Croatia has two competent authorities for MDR/IVDR: the ministry responsible for health (Ministarstvo zdravstva) and the Agency for Medicinal Products and Medical Devices (Agencija za lijek…

What the implementing act does

The implementing act does not restate the substantive device rules: it determines the competent authorities, the procedure of the competent authorities, supervision and the penalty provisio…

National implementing act NN 100/2018

The Croatian implementing act for the EU medical device and IVD regulations is the Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnos…

Croatian definitions defer to MDR/IVDR

Croatian law contains no independent definition of a medical device or an in vitro diagnostic medical device: the terms used in the implementing act have the same meaning as the terms used…

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

The route is MDR/IVDR conformity assessment, not a national registration

There is no Croatian device registration or approval procedure that a manufacturer applies for: prior to placing a device on the market the manufacturer must undertake a conformity assessme…

National market notification waived once the device is in EUDAMED

HALMED operates a national notification of placing a medical device on the market (obavijest o stavljanju medicinskog proizvoda u promet), separate from EUDAMED registration. HALMED states…

EU CE marking under MDR/IVDR — direct access to the Croatian market

statement: A device lawfully bearing CE marking under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may be placed on the Croatian market on the strength of that certificate. Croatia…

No recognition route for FDA, PMDA, MFDS or NMPA approvals

statement: Croatia is an EU member state: a device may be placed on the Croatian market only if it complies with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). A US FDA…

Sole authorised representative required for non-EU manufacturers

A manufacturer not established in a member state may place a device on the Union market — including the Croatian market — only if it designates a sole authorised representative established…

Person responsible for regulatory compliance (PRRC)

Manufacturers must have within their organisation at least one person responsible for regulatory compliance holding a relevant university degree plus one year of professional experience in…

Distributors must register before starting wholesale or retail trade

Before starting wholesale or retail trade in medical devices or in vitro diagnostic medical devices, distributors must be entered in the Croatian register of distributors. HALMED decides on…

Importers register in EUDAMED, not in the distributor register

HALMED states that importers — any natural or legal person established in the European Union that places a device from a third country on the Union market — are not entered in the Croatian…

Documents for the Croatian market notification

For the national notification of placing a device on the market HALMED requires: the completed notification form — Obrazac MEDPRO II/III for Class IIa, IIb and III medical devices or Obraza…

No source-verified answer is published for this dimension yet.

Croatian language for patient and lay information

Under Article 30 of the implementing act, data and documentation used in the implementation of the MDR and IVDR that are intended for patients and laypersons must be in the Croatian languag…

Market surveillance by the Ministry's Pharmaceutical Inspection

Supervision of the implementing act is carried out by the Ministry of Health, and the Ministry's Pharmaceutical Inspection performs market surveillance of medical devices and in vitro diagn…

Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment

Electrical safety

EMC Directive disapplied where MDR fixes the same essential requirements

EMC

HAKOM radio-equipment market access (Pravilnik o radijskoj opremi, NN 49/2016)

Wireless / radio

Entry in the register of manufacturers or authorised representatives (Upis / uskraćivanje upisa u očevidnik proizvođača ili zastupnika proizvođača)

EUR 700.00

Change of an entry in the register of manufacturers or authorised representatives (Izmjena / uskraćivanje izmjene upisa)

EUR 200.00

Class I · Self-declaration (no notified body)

0 days

HALMED decision on entry in the register of distributors · National administrative decision under NN 100/2018 Article 9(2)

30 days

HALMED decision on a classification dispute between a manufacturer and a notified body · National administrative decision under NN 100/2018 Article 11(3)-(4)

30-45 days

Notified body certificate validity — maximum five years

A CE certificate issued by a notified body under MDR/IVDR is valid for the period it indicates, which may not exceed five years; on application by the manufacturer the validity may be exten…

MDR transitional periods for Directive certificates — 31 December 2027 / 2028

Devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC that is valid by virtue of MDR Article 120(2) may still be placed on the market or put into service…

Amendment of the Croatian market notification

Where documentation filed with the initial notification of placing a device on the market changes, HALMED requires a notification of amendment referring to the last classification reference…

Relabelling or repackaging — 28 days' prior notice

A distributor or importer that translates information supplied by the manufacturer or changes the outer packaging of a device already placed on the market must inform the manufacturer and t…

EUDAMED modules mandatory from 28 May 2026

By Commission Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025, the Commission confirmed that the EUDAMED actor registration system, the UD…

Legacy devices must be in EUDAMED by 28 November 2026

Under MDR Article 123(3)(e) as inserted by Regulation (EU) 2024/1860, no later than 12 months after publication of the Commission's notice, manufacturers must ensure that the information to…

Clinical investigations and performance studies approved by the Ministry of Health

In Croatia the approval for conducting a clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device is granted by the Ministry of Health, not…

National derogation for devices without conformity assessment

On a justified request and with the consent of the health minister, HALMED may authorise the placing on the market or putting into service of medical devices and in vitro diagnostic medical…

Class I post-market surveillance report

Manufacturers of Class I medical devices must prepare a post market surveillance report summarising the results and conclusions of the analyses of the post market surveillance data gathered…

HALMED is the vigilance authority; users and patients report to it

HALMED conducts vigilance for medical devices and in vitro diagnostic medical devices in accordance with the MDR and IVDR. Economic operators report their knowledge of adverse events under…

Serious incident reporting timelines

A manufacturer must report any serious incident immediately after it has established, or considers reasonably possible, a causal relationship between the incident and its device, and not la…

Field safety corrective actions reported to HALMED

Manufacturers must report to the relevant competent authorities any field safety corrective action in respect of devices made available on the Union market, including a field safety correct…

Advertising rules for medical devices in Croatia

Advertising of medical devices in Croatia is governed by Articles 59 and 60 of the Zakon o medicinskim proizvodima (NN 76/13). Article 59(1) defines advertising of a medical device as any f…

No administrative appeal; judicial review only

Proceedings under the Croatian implementing act are conducted under the general administrative procedure law. Against acts of the competent authority no appeal is allowed, but an administra…