HALMED · structured requirements

🇭🇷 Croatia IVD regulatory data

Explore the IVD requirements currently available for Croatia, organized by topic and linked to official sources.

31 facts21 dimensions10 official sourceslatest verification 2026-09-16

Changes after registration

Common questions about changing a registered IVD in Croatia. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Notified body certificate validity — maximum five years

validity.ce-certificate-maximum-five-years

Fact-level verified

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 extended for further periods each not exceeding five years, based on a re-assessment under the applicable conformity assessment procedures. Any supplement to a certificate remains valid as long as the certificate it supplements is valid.

Conditions

Re-certification reviews and renewal of certificates are required at least every five years.
The Croatian national registration (unique registration number, EUDAMED device registration) is not time-limited in the same way and does not expire with the certificate, but the device may no longer be placed on the market if the certificate lapses without a transitional basis.

Source is the English consolidated MDR text on EUR-Lex. Verbatim: "The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures."

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authorities — Ministry of Health and HALMED

authority.two-competent-authorities

Fact-level verified

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 lijekove i medicinske proizvode, HALMED). The Ministry approves clinical investigations and performance studies, designates and notifies conformity assessment bodies, monitors notified bodies, gives consent to Agency derogation approvals and carries out supervision; the Agency verifies the data entered in the electronic registration system of economic operators and assigns the unique registration number, decides classification disputes between manufacturers and notified bodies, keeps the distributor register, approves national derogations, issues free-sale certificates, conducts device vigilance and may request additional information from health institutions.

Conditions

HALMED is the device-facing authority for economic-operator registration, the distributor register, vigilance and free-sale certificates; the Ministry of Health retains clinical investigations, notified bodies, derogation consent and market surveillance.

Croatian (source language). Article 5 verbatim: "Nadležna tijela za potrebe provedbe uredbi iz članka 2. ovoga Zakona i ovoga Zakona jesu: – ministarstvo nadležno za zdravstvo (u daljnjem tekstu: Ministarstvo) – Agencija za lijekove i medicinske proizvode (u daljnjem tekstu: Agencija)." Articles 6 and 7 then split the functions.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Amendment of the Croatian market notification

change.market-notification-amendment

Fact-level verified

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 of the Agency's receipt certificate (530-09/...), stating clearly what changed and enclosing the relevant notification form, the new product list where it changed, the proof of payment, and any other document depending on the change. HALMED notes by way of example that a change of the manufacturer's address automatically triggers a change of the labelling, instructions for use, declaration of conformity and conformity certificate.

Conditions

The amendment procedure is cited by HALMED against Article 42(3) of the Zakon o medicinskim proizvodima (NN 76/13), i.e. the legacy national provision, and is charged per the price list (change of an entry in the register of medical devices 300,00 EUR, or 200,00 EUR where the entry decision is unchanged).
Changes requiring a new or amended EU certificate must be assessed by the notified body before the national amendment is filed.

Croatian (source language). Verbatim: "U slučaju izmjene dokumentacije koja je priložena prilikom inicijalne obavijesti o stavljanju u promet medicinskih proizvoda, sukladno s čl. 42. (3) Zakona o medicinskim proizvodima (Narodne novine, br. 76/13.), potrebno je poslati obavijest o izmjeni s pozivom na posljednju klasifikacijsku oznaku (530-09/…) potvrde Agencije te jasno navesti što se izmijenilo".

Relabelling or repackaging — 28 days' prior notice

change.relabelling-repackaging-28-day-notice

Fact-level verified

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 the competent authority of the member state in which it plans to make the device available at least 28 days before making the relabelled or repackaged device available, and must supply a sample or mock-up on request. Croatian law makes failure to give that notice an offence punishable on the legal person with a fine in the range of 50.000,00 to 200.000,00 kuna.

Conditions

The activity must be covered by a QMS with procedures ensuring accurate and up-to-date translation and preservation of the original condition of the device, and a notified body certificate attesting that the QMS meets MDR Article 16(3) must be submitted to the competent authority within the same 28-day period.
The distributor or importer must indicate on the device or its packaging or accompanying document the activity carried out together with its name, registered trade name or trademark, registered place of business and contact address.

Source is the English consolidated MDR text on EUR-Lex. Verbatim: "At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use."

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical investigations and performance studies approved by the Ministry of Health

clinical-investigation.ministry-of-health-approval

Fact-level verified

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 by HALMED. A positive opinion of the Central Ethics Committee is an integral part of the approval procedure. The approval is granted or refused by decision against which no appeal lies, but an administrative dispute may be initiated. The Ministry also monitors and supervises the conduct of clinical investigations and performance studies and takes corrective measures.

Conditions

Investigations may not be conducted on prisoners or on persons in whom coercion could influence consent.
The sponsor must insure against liability for injury, death or treatment of a subject connected with the investigation before it begins, and the investigation is conducted at the sponsor's expense under a contract with the legal person conducting it.
Penalties in the act track the MDR reporting deadlines for suspension, early termination (15 days, or 24 hours for safety reasons) and the final report (one year from completion, three months from early termination or suspension).

Croatian (source language). Article 16(1) verbatim: "Ministarstvo daje odobrenje za provođenje kliničkog ispitivanja medicinskog proizvoda i studije učinkovitosti in vitro dijagnostičkog medicinskog proizvoda." Article 16(3): "Sastavni dio postupka odobravanja ... je pozitivno mišljenje Središnjeg etičkog povjerenstva." Article 6 first indent gives the Ministry the corresponding competence.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Croatian definitions defer to MDR/IVDR

scope.definitions-follow-mdr-ivdr

Fact-level verified

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 in Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Scope is therefore determined by Article 2 of the MDR and Article 2 of the IVDR, including the products without an intended medical purpose listed in MDR Annex XVI.

Conditions

HALMED's public 'basic concepts' page still reproduces the device definition from the repealed Directive-era Zakon o medicinskim proizvodima (NN 76/13, Article 3); the operative definition is the MDR/IVDR one per Article 3 of NN 100/2018.

Croatian (source language). Verbatim: "Pojmovi u smislu ovoga Zakona imaju jednako značenje kao pojmovi uporabljeni u Uredbi (EU) 2017/745 i Uredbi (EU) 2017/746." Translation: "Terms in the sense of this Act have the same meaning as the terms used in Regulation (EU) 2017/745 and Regulation (EU) 2017/746."

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Documents for the Croatian market notification

dossier.market-notification-documents

Fact-level verified

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 Obrazac IVD-MEDPRO for in vitro diagnostic medical devices; an Excel list of the products; the conformity certificate (EC certificate, with any supplement relating to Regulations (EU) 2023/607 and 2024/1860) and the EU declaration of conformity, in ZIP format; a labelling sample (box) and the instructions for use, in ZIP format; and proof of payment of the procedure fee. Products covered by the same EC certificate may be listed together and filed as one notification.

Conditions

The dossier is a national notification dossier, not a technical file: HALMED does not re-assess the technical documentation.
For devices already registered in EUDAMED with Croatia listed as a distribution market, no notification is filed.
A change to any document filed with the initial notification triggers a notification of amendment.

Croatian (source language). The excerpt reproduces the documentation bullets of the HALMED page verbatim, in page order.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Sole authorised representative required for non-EU manufacturers

operators.authorised-representative-mandatory

Fact-level verified

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 in the Union. The designation is valid only when accepted in writing and must be effective at least for all devices of the same generic device group; the authorised representative must be able to perform the mandated tasks, including verifying that the EU declaration of conformity and technical documentation have been drawn up and holding them at the disposal of competent authorities.

Conditions

The authorised representative must have permanently and continuously at his or her disposal at least one person responsible for regulatory compliance with the qualifications set out in MDR Article 15(6).
HALMED registers the authorised representative together with manufacturers and importers and assigns a unique registration number (Article 10 NN 100/2018); EUDAMED actor registration produces the SRN.
HALMED's register of custom-made device manufacturers is open to Croatian-established representatives of third-country manufacturers acting as authorised representatives on Union territory.

Source is the English consolidated MDR text on EUR-Lex. Verbatim Article 11(1): "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." Article 11(2) requires written acceptance and coverage of at least the same generic device group.

Person responsible for regulatory compliance (PRRC)

operators.prrc-required

Fact-level verified

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 regulatory affairs or QMS relating to medical devices, or four years of such experience. Micro and small enterprises may have the PRRC permanently and continuously at their disposal instead of within the organisation. The PRRC is responsible for checking device conformity under the QMS before release, keeping technical documentation and the EU declaration of conformity up to date, and ensuring post-market surveillance, reporting and investigation obligations are met.

Conditions

Croatian registration procedures require proof that the person responsible for compliance satisfies MDR Article 15 and takes on the obligations of Article 15(3) — HALMED makes this an express document in the register of custom-made device manufacturers.
Custom-made device manufacturers may demonstrate the expertise with at least two years of professional experience in a relevant field of manufacturing.
A change of the person responsible for regulatory compliance in EUDAMED is a charged change item on the HALMED price list (100,00 EUR).

Source is the English consolidated MDR text on EUR-Lex. Verbatim Article 15(1): "Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices." Article 15(2) exempts micro and small enterprises from having the person in the organisation.

Registration of manufacturers, authorised representatives and importers

operators.registration-and-unique-number

Fact-level verified

On an application for registration filed through the electronic system by a manufacturer, an authorised representative or an importer, HALMED verifies the data entered and, once it establishes their validity and compliance with the implementing act and with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, assigns the applicant a unique registration number. This is the Croatian registration step for economic operators; it is not a product approval.

Conditions

The registration fee is charged per the HALMED price list, group 8, items 1-2 (700,00 EUR for registration / 200,00 EUR for a change of registration in the register of manufacturers or manufacturer representatives).
Since the EUDAMED actor module became mandatory on 28 May 2026, the SRN issued through EUDAMED is what the operator uses to lodge conformity-assessment applications and to register devices.

Croatian (source language). Verbatim: "Agencija će na zahtjev za registraciju proizvođača, ovlaštenog zastupnika ili uvoznika podnesenog putem elektroničkog sustava provjeriti podatke unesene u elektronički sustav te, nakon što utvrdi njihovu valjanost i usklađenost s odredbama ovoga Zakona, Uredbe (EU) 2017/745 i Uredbe (EU) 2017/746 dodijeliti podnositelju zahtjeva jedinstveni registracijski broj."

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Distributors must register before starting wholesale or retail trade

establishment.distributor-register

Fact-level verified

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 the entry within 30 days of receiving a complete request; no appeal lies against the decision, but an administrative dispute may be initiated. The obligation does not extend to persons authorised to carry out pharmacy activity under a separate law.

Conditions

Conditions for entry are prescribed by a rulebook of the health minister and, per HALMED, require premises and/or qualified equipment allowing receipt, separate storage of devices, maintenance of the manufacturer's storage and transport conditions, segregation of non-conforming, recalled and withdrawn devices, and stock rotation by receipt or expiry date.
Persons previously entered in the register of medical-device wholesalers or holding a retail authorisation continue to work on those authorisations; on a change they may request an amendment or apply for entry in the distributor register.
Registration and maintenance fees are on the HALMED price list, group 8, items 30-68.

Croatian (source language). Article 9(1) verbatim: "Prije početka obavljanja djelatnosti prometa na veliko i malo medicinskim proizvodima i in vitro dijagnostičkim medicinskim proizvodima distributeri se upisuju u registar distributera." Article 9(2): "Rješenje o upisu u registar distributera donosi Agencija u roku od 30 dana od dana dostave urednog zahtjeva."

Importers register in EUDAMED, not in the distributor register

establishment.importer-eudamed-not-distributor-register

Fact-level verified

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 register of distributors, but are obliged to register in EUDAMED and are issued a unique registration number (SRN). An importer that also distributes medical devices within the EU must, in addition to EUDAMED, be entered in the distributor register. Operators previously entered in the register of medical-device wholesalers that wish to continue importing devices from third countries must register in EUDAMED as an importer.

Conditions

An importer must also meet the MDR Article 13 obligations, including indicating its name and registered place of business on the device, its packaging or the accompanying documentation.
The HALMED price list carries an annual maintenance item for importers ("Održavanje statusa uvoznici", 250,00 EUR).

Croatian (source language). Verbatim: "Uvoznik je svaka fizička ili pravna osoba s poslovnim nastanom u Europskoj uniji koja medicinski proizvod iz treće zemlje stavlja na tržište Unije. Uvoznici se ne upisuju u registar distributera, već su obvezni registrirati se u bazi Eudamed te im se izdaje jedinstveni registracijski broj ("SRN"). Uvoznici koji se bave i distribucijom medicinskih proizvoda unutar teritorija EU, osim u Eudamed, upisuju se i u registar distributera."

Fees

What regulator fee applies to this class, route, event, and date?

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HALMED medical-device fees (group 8)

fees.halmed-medical-device-tariff

Fact-level verified

HALMED charges fixed fees for medical-device procedures under group 8 of its price list, in euro excluding VAT, under a price list in force since 9 March 2024 with amendments effective 1 July 2024 and 1 April 2025. Key items: entry in the register of manufacturers or manufacturer representatives 700,00 EUR, change of registration 200,00 EUR; entry in the register of medical devices 800,00 EUR for 1-5 products, 900,00 EUR for 6-30 products and 1.000,00 EUR for more than 30; change of an entry in the register of medical devices 300,00 EUR (200,00 EUR where the registration decision is unchanged); risk classification of a medical device 1.000,00 EUR plus additional costs if an external expert is engaged; issue of an SRN 400,00 EUR (micro), 600,00 EUR (small) and 800,00 EUR (medium/large); free-sale certificate per country 150,00-380,00 EUR depending on the number of products; entry in the distributor register 400,00-1.050,00 EUR depending on enterprise size and number of branches; maintenance of manufacturer/authorised-representative status in Croatia 200,00-800,00 EUR by number of products, and of importer status 250,00 EUR (the price list does not state the period of the maintenance fee; its footnote says items 10-19 begin to be charged under MDR Articles 29 and 30, the EUDAMED registration duty).

Conditions

Fees are set not by the act but by the price list issued under Article 28 NN 100/2018, which provides that the minister determines by decision the fees for activities under the two Union regulations.
Prices are in euro without VAT; the price list records the health minister's consent of 29 February 2024, 17 May 2024 and 13 March 2025.
Applicants must use the Web ponuda application to generate the payment offer.

Croatian (source language). The excerpt reproduces group 8 price-list lines verbatim. Text: "Upis / uskraćivanje upisa u očevidnik proizvođača ili zastupnika proizvođača — 700,00 EUR"; "Upis / uskraćivanje upisa u očevidnik medicinskih proizvoda (1 do 5 proizvoda) — 800,00 EUR"; "Razvrstavanje medicinskog proizvoda s obzirom na klasu rizika — 1.000,00 EUR + dodatni troškovi ako je uključen vanjski stručnjak"; "Izdavanje SRN broja - mikro poduzeća — 400,00 EUR". Prices are stated in euro and exclude VAT.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Croatian language for patient and lay information

label-ifu.croatian-language-required

Fact-level verified

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 language. Data and documentation intended for competent authorities, or exclusively for use in the performance of health-care activity, may be in Croatian and/or English. Certificates issued by notified bodies must be at least in the Croatian language, and the competent authorities draw up procedural documentation in Croatian.

Conditions

The duty is backed by penalties: Article 32(1) point 8 of the act fines a manufacturer (legal person) 50.000,00 to 200.000,00 kuna if the MDR Annex I Section 23 information accompanying the device for the user or patient is not provided in Croatian; point 9 applies the same to the IVDR Annex I Section 17 information. A sole trader is fined 10.000,00 to 60.000,00 kuna and the responsible person 5.000,00 to 8.000,00 kuna (Article 32(2)-(3)).
The rule implements MDR Article 10(11) and IVDR Article 10(10), which leave the language of the information to the member state.

Croatian (source language). Article 30(1) verbatim: "Podaci i dokumentacija koji se koriste u provedbi uredbi iz članka 2. ovoga Zakona, a namijenjeni su pacijentima i laicima, moraju biti na hrvatskom jeziku." Article 30(2): "... a namijenjeni su nadležnim tijelima ili isključivo za uporabu u obavljanju zdravstvene djelatnosti, mogu biti na hrvatskom i/ili engleskom jeziku." Article 30(3): "Potvrde koje izdaju prijavljena tijela ... moraju biti najmanje na hrvatskom jeziku."

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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What the implementing act does

legal-basis.implementing-act-scope

Fact-level verified

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 provisions for implementing the two EU regulations. Its substantive provisions are limited to the national layer — the distributor register, the unique registration number for manufacturers, authorised representatives and importers, the registration of custom-made device manufacturers, the national derogation, clinical investigation approval, vigilance, market surveillance, fees and the national language rule.

Conditions

Article 1(2) applies the act to medical devices and in vitro diagnostic medical devices.

Effective from 2018-11-22

Croatian (source language). Article 1(1) verbatim: "Ovim se Zakonom utvrđuju nadležna tijela, postupanje nadležnih tijela, nadzor te prekršajne odredbe za provedbu uredbi Europske unije iz članka 2. ovoga Zakona." Translation: "This Act determines the competent authorities, the conduct of the competent authorities, supervision and the penalty provisions for the implementation of the European Union regulations referred to in Article 2 of this Act."

National implementing act NN 100/2018

legal-basis.national-implementing-act

Fact-level verified

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 dijagnostičkim medicinskim proizvodima, published in Narodne novine no. 100/2018 of 14 November 2018 and adopted by the Croatian Parliament on 31 October 2018. It enters into force on the eighth day after publication, i.e. 22 November 2018.

Conditions

The act remains the national implementing instrument in force as of 2026-09-15; HALMED's legislative-framework page lists no amending act for it.
It sits alongside the older Zakon o medicinskim proizvodima (NN 76/13), which HALMED still cites for advertising (Articles 59-60), the register of custom-made device manufacturers and the register of Class I devices.

Effective from 2018-11-22

Croatian (source language). Article 34 verbatim: "Ovaj Zakon stupa na snagu osmoga dana od dana objave u »Narodnim novinama«." Translation: "This Act enters into force on the eighth day from the day of its publication in the Official Gazette." Publication date 14 November 2018 is stated in the gazette header of the same document.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Market surveillance by the Ministry's Pharmaceutical Inspection

qms.market-surveillance-by-pharmaceutical-inspection

Fact-level verified

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 diagnostic medical devices, of notified bodies, and of the conduct of clinical investigations and performance studies. If a pharmaceutical inspector orders testing of a device, the cost is borne by the person who placed that device on the market or into use. Legal and natural persons must enable the inspection and, on request, make available the necessary quantity of samples and provide the necessary data.

Conditions

If the inspector finds physical resistance, police assistance may be requested.
The inspector must file an indictment or report with the competent body within 15 days of the end of the supervision.

Croatian (source language). Article 20(2) verbatim: "Farmaceutska inspekcija Ministarstva obavlja nadzor tržišta medicinskih proizvoda i in vitro dijagnostičkih medicinskih proizvoda, prijavljenih tijela te nadzor nad provedbom kliničkih ispitivanja medicinskih proizvoda i provedbom studija učinkovitosti in vitro dijagnostičkih medicinskih proizvoda."

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Field safety corrective actions reported to HALMED

recall.field-safety-corrective-action-reporting

Fact-level verified

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 corrective action undertaken in a third country in relation to a device also lawfully made available on the Union market where the reason is not limited to the third-country device. In Croatia the competent authority for these reports is HALMED, which conducts device vigilance under Article 19(1) of the implementing act. Except in urgent cases, the field safety corrective action must be reported in advance of being undertaken.

Conditions

The safety notice communicating the corrective action to users must be issued without delay (MDR Article 89(8)); failure to do so is an offence under Article 31(1) point 54 of NN 100/2018 (fine 100.000,00 to 700.000,00 kuna for a legal person).
Failure by a manufacturer to submit a serious incident and field safety corrective action report to the Agency is an offence under Article 31(1) point 53 of NN 100/2018.

Source is the English consolidated MDR text on EUR-Lex. Verbatim Article 87(1)(b): "any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country." Article 87(8): "Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being undertaken."

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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

pathways.conformity-assessment-under-mdr-ivdr

Fact-level verified

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 assessment in accordance with the applicable procedures in MDR Annexes IX to XI (IVDR Annexes IX to XI correspondingly), using a notified body unless the device is Class I and self-certified. The Croatian layer is the registration of the economic operator and of the device, not the approval of the product.

Conditions

Class I devices that are not sterile, do not have a measuring function and are not reusable surgical instruments may be placed on the market on the manufacturer's own EU declaration of conformity without a notified body.
Devices with a certificate issued under Directive 93/42/EEC may still be placed on the market under the transitional regime in MDR Article 120(3a) while the conditions in Article 120(3c) remain met (see the separate approval-validity fact).

Source is the English consolidated MDR text on EUR-Lex. Verbatim: "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."

National market notification waived once the device is in EUDAMED

pathways.market-notification-waived-by-eudamed

Fact-level verified

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 that for devices entered in the European database EUDAMED no notification of placing on the market needs to be sent, provided the Republic of Croatia is named as a market in which the device is distributed. Devices that are not in EUDAMED must be notified to HALMED.

Conditions

Notified devices: the manufacturer submits the MEDPRO-II/III form for Class IIa, IIb and III devices or the IVD-MEDPRO form for IVDs, a product list, the EC certificate and EU declaration of conformity, a labelling sample and the instructions for use, and proof of payment.
Because the EUDAMED devices module became mandatory on 28 May 2026, the practical effect from that date is that a CE holder that has registered the device in EUDAMED with Croatia listed does not file the national notification.
Changes to the documents filed with a notification require a notification of amendment (see the change-control fact).

Croatian (source language). Verbatim: "Za medicinske proizvode koji su upisani u europsku bazu Eudamed nije potrebno slati obavijesti o stavljanju u promet (RH mora biti navedena kao tržište na kojem se proizvod distribuira)." Translation: "For medical devices entered in the European Eudamed database it is not necessary to send a notification of placing on the market (Croatia must be named as a market in which the device is distributed)."

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Croatia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Croatia (3 records)

CroatiaUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

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

reliance.no-route-for-non-ce-approvals

Fact-level verified

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 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration certificate is not recognised by HALMED and opens no abridged, documentary, fast-track or reciprocal route; the holder must obtain CE marking through a notified body under MDR/IVDR before the device may lawfully be placed on the Croatian market. The only exception is a public-health derogation under Article 59 MDR / Article 54 IVDR, which Croatia implements nationally in Article 14 of NN 100/2018 and which authorises a specific device for a limited purpose; it is not recognition of a foreign approval.
Source Approval: none
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Croatia applies MDR and IVDR directly; the national implementing act (NN 100/2018) adds national duties and penalties but no separate product approval for CE-marked devices.
A third-country approval can be used inside the technical documentation as supporting evidence, but no Croatian or Union provision examines or accepts it in place of conformity assessment.
Derogation route (Article 14 NN 100/2018, MDR Article 59 / IVDR Article 54): Agency decision on a justified request with the health minister's consent, notified to the Commission and the other member states.
Applies equally to medical devices and to in vitro diagnostic devices, which are not CE-marked but carry the CE marking under IVDR.

Source is the English consolidated MDR text on EUR-Lex. Verbatim: "A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose." The IVDR equivalent is Article 5(1) of Regulation (EU) 2017/746. The Croatian implementing act's only gateway for a non-conforming device is Article 14 (national derogation).

CroatiaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima (NN 100/2018) — Article 9(2) register-of-distributors decision and Article 11(3)-(4) classification-dispute decision

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

CroatiaEU conformity assessment

Prior approval / evidence record

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

reliance.eu-ce-marking-single-market-access

Fact-level verified

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 secures the implementation of the two Union regulations by the Zakon o provedbi Uredbe (EU) 2017/745 ... (NN 100/2018), which establishes the national competent authorities, the national procedural duties and the penalties, but creates no additional national product approval, no national certificate and no national re-assessment of the notified body's technical assessment.
Source Approval: EU CE Marking under MDR (EU) 2017/745 / IVDR (EU) 2017/746
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: No

Conditions

The CE certificate must be issued by a notified body designated under MDR/IVDR for the device class and, for Class I devices, the manufacturer's own EU declaration of conformity applies.
Local duties still attach to the CE holder: registration of the manufacturer/authorised representative/importer with a unique registration number (Article 10 NN 100/2018), device registration in EUDAMED, the distributor register where the holder also distributes, Croatian-language information for patients and lay users (Article 30), market notification where the device is not in EUDAMED with Croatia listed, and vigilance reporting to HALMED.
Croatia applies MDR and IVDR directly; the implementing act exists to designate authorities and add national procedure, not to re-approve the device.
Applies equally to medical devices under the MDR and to in vitro diagnostic medical devices, which carry the CE marking under the IVDR.

Croatian (source language). Verbatim: "Ovim se Zakonom osigurava provedba sljedećih uredbi Europske unije: – Uredbe (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. o medicinskim proizvodima ... – Uredbe (EU) 2017/746 Europskog parlamenta i Vijeća od 5. travnja 2017. o in vitro dijagnostičkim medicinskim proizvodima ...". Translation: "This Act secures the implementation of the following European Union regulations: Regulation (EU) 2017/745 ... Regulation (EU) 2017/746 ...".

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Ministry approval of clinical investigations is given by decision with no statutory period; the MDR Article 70 periods apply directly

clock.clinical-investigation-approval-no-statutory-period

Fact-level verified

The Ministry of Health grants or refuses approval to conduct a clinical investigation of a medical device or a performance study of an IVD by a decision (rješenje) against which no appeal lies but an administrative dispute may be brought; a positive opinion of the Central Ethics Committee is an integral part of the approval procedure, and the Minister prescribes the criteria for conducting investigations by ordinance. The Act fixes no period for the Ministry's decision, so the validation and decision periods of MDR Article 70 (IVDR Article 66) govern the national handling.

Conditions

MDR Article 70(7)(b) requires notified authorisation before class III or invasive class IIa/IIb investigations start, with no valid negative ethics opinion. The 45-day authorisation period may extend 20 days for expert consultation and pauses for requested information under Article 70(6); expiry alone does not authorise commencement.
The Act's only statutory decision clocks are the 30-day distributor-register decision (Article 9(2)) and the 30-day classification-dispute decision extendable by 15 days (Article 11(3)–(4)), already recorded; the sponsor-side 15-day notifications in the penalty provisions restate MDR Article 77.

Effective from 2018-11-22

MDR consolidated text, 19 July 2026 IVDR consolidated text, 10 January 2025

Croatian source. Translation: '(1) The Ministry grants approval for conducting a clinical investigation of a medical device and a performance study of an in vitro diagnostic medical device. (2) The Ministry grants or refuses the approval by a decision against which no appeal is permitted but an administrative dispute may be initiated. (3) A positive opinion of the Central Ethics Committee is an integral part of the approval procedure. (4) The criteria for conducting clinical investigations and performance studies are prescribed by the minister by ordinance.' The absence of a decision period was checked by full-text search of the Act for every 'dana' / 'rok' occurrence: the hits are Articles 9(2), 11(3)–(4), the inspector's 15-day reporting duty, the sponsor- and notified-body-side deadlines in the penalty articles, and the 18-month deadline for adopting ordinances. No device-specific ordinance under Article 16(4) was found in Narodne novine; the Ministry's published clinical-trial procedure document concerns medicinal products under the Medicines Act.

Statutory decision periods in the implementing act

review-clocks.statutory-decision-periods

Fact-level verified

The implementing act fixes two decision clocks: HALMED decides on entry in the register of distributors within 30 days of receipt of a complete request, and it must decide a classification dispute between a manufacturer and a notified body within 30 days of receipt of a complete request, extended by 15 days where it requests supplementary documentation. No statutory clock is set for the issuance of the unique registration number or of free-sale certificates.

Conditions

These are procedural clocks for national administrative acts, not review clocks for product approval: Croatia has no product approval clock because conformity assessment runs under MDR/IVDR with a notified body.
Against both decisions no appeal lies; an administrative dispute may be initiated (Article 29(2)).

Croatian (source language). Article 9(2): "Rješenje o upisu u registar distributera donosi Agencija u roku od 30 dana od dana dostave urednog zahtjeva." Article 11(4): "Agencija može u postupku iz stavka 1. ovoga članka od podnositelja zahtjeva zatražiti nadopunu dokumentacije, pri čemu se rok iz stavka 3. ovoga članka produžuje za 15 dana."

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

National derogation for devices without conformity assessment

special-access.national-derogation-art-59-mdr

Fact-level verified

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 devices for which conformity assessment procedures have not been carried out, where this is in the interest of public health, or of safety or health of patients. The authorisation is granted or refused by decision against which no appeal lies, but an administrative dispute may be initiated; HALMED informs the European Commission and the other member states of the authorisations granted. This is the national implementation of the MDR Article 59 / IVDR Article 54 derogation and is the only route by which a device without CE marking — including a device holding only an FDA, PMDA, MFDS or NMPA approval — can lawfully reach the Croatian market.

Conditions

The derogation is device- and situation-specific and is not a route to market for a foreign approval held as a matter of routine; it requires a public-health or patient safety justification.
The fee on the HALMED price list group 8 is 1.000,00 EUR for a derogation from the conformity assessment procedure (MDR Article 59 / IVDR Article 54).

Croatian (source language). Verbatim Article 14(1): "Agencija može na osnovi utemeljenog zahtjeva te uz suglasnost ministra odobriti stavljanje na tržište ili u uporabu i one medicinske proizvode i in vitro dijagnostičke medicinske proizvode za koje nisu provedeni postupci ocjenjivanja sukladnosti ako je to od interesa za javno zdravlje ili sigurnost ili zdravlje pacijenata." Article 14(3): "Agencija o odobrenjima iz stavka 1. ovoga članka obavještava Europsku komisiju i druge države članice Europske unije."

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

Harmonised standards published in the Official Journal give a presumption of conformity; no Croatian standards list exists

standards.harmonised-standards-presumption

Fact-level verified

Devices in conformity with the relevant harmonised standards, or the relevant parts of them, whose references have been published in the Official Journal of the European Union are presumed to conform to the requirements of Regulation (EU) 2017/745 covered by those standards. The presumption also covers system or process requirements on economic operators or sponsors, including quality management, risk management, post-market surveillance, clinical investigations, clinical evaluation and post-market clinical follow-up. The Croatian implementing act contains no standards provision, so this directly applicable Union rule is the operative one.

Conditions

IVDR equivalent: Article 8 of Regulation (EU) 2017/746.
Harmonised European standards are adopted nationally by the Croatian Standards Institute (HZN) as HRN EN standards; neither HALMED nor the Ministry maintains a device standards list.

Effective from 2021-05-26

English source. The absence of a standards provision in the implementing act was checked by full-text search of NN 100/2018 for 'norm' (Croatian for standard), which returns no hit.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

No administrative appeal; judicial review only

appeal.no-appeal-administrative-dispute

Fact-level verified

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 administrative dispute may be initiated. This applies to the Agency's decisions on entry in the register of distributors, on classification disputes, on registration of economic operators, on derogation approvals and on refusals of clinical investigation approval, since the act repeats the rule for each of those procedures.

Conditions

The consequence for a manufacturer is that a negative Croatian decision must be challenged before the administrative court rather than through a ministry-level appeal.
The rule is stated generically in Article 29(2) and repeated in Articles 9(3), 11(5), 14(2) and 16(2).

Croatian (source language). Verbatim Article 29: "(1) Postupci propisani ovim Zakonom rješavaju se sukladno zakonu kojim se uređuje opći upravni postupak. (2) Protiv akata nadležnog tijela nije dopuštena žalba, ali se može pokrenuti upravni spor."

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

EUDAMED modules mandatory from 28 May 2026

udi.eudamed-modules-mandatory-28-may-2026

Fact-level verified

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 UDI and device registration system, the notified bodies and certificates system and the market surveillance system are functional and meet their functional specifications. Under the six-month rule introduced by Regulation (EU) 2024/1860 into MDR Article 123(3)(d) and IVDR Article 113(3), the obligations and requirements relating to those electronic systems apply from six months after publication of that notice, i.e. from 28 May 2026. From that date devices must be registered in EUDAMED before being placed on the Union market, and the parallel national registration regimes cease to be sufficient.

Conditions

State as of 2026-09-15: the actor, UDI/devices, notified bodies/certificates and market surveillance modules have been mandatory since 28 May 2026; the vigilance and clinical investigation modules are not yet declared functional.
Manufacturers must first register as economic operators and obtain an SRN before registering devices.
The notified bodies and certificates module carries an 18-month period (to 28 May 2027) for notified bodies to upload legacy certificate information.

Effective from 2025-11-27

Croatian language version of the OJ decision (source language of the retrieved text; the decision is equally authentic in all EU languages). Verbatim Article 1: "Potvrđuje se da su sljedeći elektronički sustavi uključeni u Europsku bazu podataka za medicinske proizvode (Eudamed) funkcionalni i da ispunjavaju funkcionalne specifikacije ... (a) elektronički sustav za registraciju gospodarskih subjekata ... (b) baza podataka jedinstvene identifikacije proizvoda i elektronički sustav za registraciju proizvoda ... (c) elektronički sustav za prijavljena tijela i potvrde ... (d) elektronički sustav za nadzor tržišta ...". Recital 5 links the six-month transition periods to MDR Article 123(3)(d)-(ec).

Legacy devices must be in EUDAMED by 28 November 2026

udi.legacy-device-registration-deadline-28-nov-2026

Fact-level verified

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 be entered in EUDAMED under MDR Article 29 is entered in that system, including for devices for which the manufacturer has undertaken a conformity assessment under Article 52 and for devices placed on the market under Article 120(3), (3a) or (3b) (unless already registered in EUDAMED). With publication on 27 November 2025, that deadline is 28 November 2026. HALMED reproduces the same deadline for Croatia: the additional six-month period for registering devices placed on the market before the mandatory-use date runs to 28 November 2026.

Conditions

State as of 2026-09-15: the deadline is still in the future (28 November 2026); devices first placed on the market on or after 28 May 2026 must be registered in EUDAMED before being placed on the market.
The obligation covers the devices entered in the UDI/device module, i.e. the UDI-DI and the core data of MDR Article 29.

Effective from 2024-07-09

Source is the English OJ text of Regulation (EU) 2024/1860. Verbatim: "(e) no later than 12 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), points (a) and (b), manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 29 is entered in that electronic system, including regarding the following devices, provided that those devices are also placed on the market from 6 months from the date of publication of that notice: (i) devices, other than custom-made devices, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52; (ii) devices, other than custom-made devices, placed on the market pursuant to Article 120(3), (3a) or (3b), unless the device, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52, is already registered in Eudamed;". HALMED's notification page states the resulting date in Croatian.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

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

vigilance.halmed-conducts-vigilance

Fact-level verified

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 those regulations; healthcare workers, users and patients report adverse events connected with devices directly to HALMED, and HALMED keeps a record of all reports received from healthcare workers, users and patients. The Ministry and HALMED take measures to encourage such reporting.

Conditions

Adverse-event terminology and timelines follow MDR Articles 87-89 and IVDR Articles 82-84; the national act does not set separate timelines.
HALMED's public vigilance page also states that the national framework rulebook is the Pravilnik o praćenju štetnih događaja vezano uz medicinske proizvode (NN 125/13), which leans on the Commission's MEDDEV 2.12 guidelines.

Croatian (source language). Article 19(1) verbatim: "Agencija provodi vigilanciju medicinskih proizvoda i in vitro dijagnostičkih medicinskih proizvoda u skladu s odredbama uredbi iz članka 2. ovoga Zakona." Article 19(3): "Zdravstveni radnici, korisnici i pacijenti saznanja o štetnim događajima povezanim s medicinskim proizvodima i in vitro dijagnostičkim medicinskim proizvodima prijavljuju Agenciji."

Serious incident reporting timelines

vigilance.serious-incident-reporting-timelines

Fact-level verified

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 later than 15 days after becoming aware of the incident. In the event of a serious public health threat the report must be provided immediately and not later than 2 days after the manufacturer becomes aware of the threat. In the event of death or an unanticipated serious deterioration in a person's state of health the report must be provided immediately after the manufacturer establishes or suspects a causal relationship, and not later than 10 days after becoming aware of the incident. Reports are submitted through the electronic system referred to in MDR Article 92.

Conditions

For similar serious incidents with an identified root cause, a periodic summary report may replace individual reports where the coordinating competent authority agrees the format, content and frequency.
Field safety corrective actions must be reported in advance of being undertaken unless urgency requires immediate action.

Source is the English consolidated MDR text on EUR-Lex. Verbatim Article 87(3): "Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident." Article 87(4): 2 days for a serious public health threat. Article 87(5): 10 days for death or unanticipated serious deterioration.

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Croatia registration →

Country

Croatia

Jurisdiction Id

croatia

Country Code

Flag

🇭🇷

Regulator

Agencija za lijekove i medicinske proizvode (HALMED)

Regulator Abbrev

HALMED

Region

europe

Tier

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Self-declaration (no notified body)
Official Timeline
Min
0
Max
0
Unit
days
Verification Status
official-verified
Official Source
Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-09-16
Realistic Timeline
Min
6
Max
9
Notes
MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
Elapsed time is EUDAMED actor and device registration plus HALMED's register entry under NN 100/2018, neither of which has a guaranteed processing time
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
croatia-distributor-register-decision
Class Name
HALMED decision on entry in the register of distributors
Risk Level
low
Pathway
National administrative decision under NN 100/2018 Article 9(2)
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima (NN 100/2018) — Article 9(2) register-of-distributors decision and Article 11(3)-(4) classification-dispute decision
Url
https://narodne-novine.nn.hr/clanci/sluzbeni/2018_11_100_1930.html
Effective Date
2018-11-22
Accessed Date
2026-09-16
Realistic Timeline
Min
30
Max
60
Unit
days
Notes
This is the national competent-authority clock, not a conformity-assessment clock: 'Rješenje o upisu u registar distributera donosi Agencija u roku od 30 dana od dana dostave urednog zahtjeva'
The clock runs from delivery of a complete request, so it does not start while the Agency is waiting for supplements, which is why the realistic range is wider than the published period
Against the decision no appeal lies; an administrative dispute may be initiated (Article 29(2))
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
croatia-classification-dispute-decision
Class Name
HALMED decision on a classification dispute between a manufacturer and a notified body
Risk Level
medium
Pathway
National administrative decision under NN 100/2018 Article 11(3)-(4)
Official Timeline
Min
30
Max
45
Unit
days
Verification Status
official-verified
Official Source
Title
Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima (NN 100/2018) — Article 9(2) register-of-distributors decision and Article 11(3)-(4) classification-dispute decision
Url
https://narodne-novine.nn.hr/clanci/sluzbeni/2018_11_100_1930.html
Effective Date
2018-11-22
Accessed Date
2026-09-16
Realistic Timeline
Min
30
Max
45
Unit
days
Notes
Article 11(3)-(4) of NN 100/2018 gives HALMED the decision where a manufacturer and a notified body disagree over the application of the classification rules; Article 11(3) sets 30 days from receipt of a complete request and Article 11(4) extends the period by 15 days where supplements are requested, so the published period is 30 to 45 days
This is a dispute-resolution clock for a national administrative act, not a route onto the market: the Union class itself remains the manufacturer's determination under MDR Annex VIII, and HALMED's own risk-classification service is a paid opinion on its price list
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
FDA 510(k)/PMA
Accepted
No
Benefit
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Key Requirements

EU Authorized Representative for non-EU manufacturers (MDR Article 22), whose mandate is registered in EUDAMED
HALMED entry in the register of manufacturers or authorised representatives (očevidnik proizvođača ili zastupnika proizvođača) — EUR 700.00 per entry
Entry of each device in the register of medical devices (očevidnik medicinskih proizvoda) — EUR 800.00 to EUR 1,000.00 by number of products
Single Registration Number (SRN) issued by HALMED — EUR 400.00 to EUR 800.00 by enterprise size
EUDAMED actor and device registration under MDR Articles 29 and 30, the duty the price list footnotes for its status-maintenance items
Distributors whose place of business is in Croatia must be entered in the register of distributors, decided within 30 days (NN 100/2018 Article 9(2))
Croatian-language instructions for use and labelling for patients and laypersons (NN 100/2018 Article 30), with penalties under Article 32(1)(8) and (9)
Market notification (obavijest o stavljanju u promet) to HALMED, waived where EUDAMED already lists the device for Croatia
Clinical investigations are approved by the Ministry of Health (NN 100/2018 Article 16)
Device features that are radio equipment also need the HAKOM route under the Pravilnik o radijskoj opremi (NN 49/2016), and measuring-instrument features need DZM type examination and verification
Medical equipment that produces ionizing radiation also needs the Civil Protection Directorate's odobrenje for activities with ionizing-radiation sources (NN 54/18, 6/22)

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources

Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-09-16
Title
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
Url
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
Effective Date
2027-02-25
Accessed Date
2026-09-16
Title
Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima (NN 100/2018) — Article 9(2) register-of-distributors decision and Article 11(3)-(4) classification-dispute decision
Url
https://narodne-novine.nn.hr/clanci/sluzbeni/2018_11_100_1930.html
Effective Date
2018-11-22
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by HALMED. Appoint a EU Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to HALMED including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
HALMED reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. HALMED may issue questions.
Duration
0 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, HALMED issues Croatia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Croatia fees →

Jurisdiction Id

croatia

Country

Croatia

Country Code

Authority

HALMED

Low Risk Local

Min: 200
Max: 800
Currency: EUR
Per Product: No

High Risk Local

Min: 900
Max: 1050
Currency: EUR
Per Product: No

Details

Id
manufacturer-register-entry
Item
Entry in the register of manufacturers or authorised representatives (Upis / uskraćivanje upisa u očevidnik proizvođača ili zastupnika proizvođača)
Currency
EUR
Amount Local
700
Amount Local Formatted
EUR 700.00
Frequency
Per application
Notes
Group 8 item 1 of the HALMED price list.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
manufacturer-register-change
Item
Change of an entry in the register of manufacturers or authorised representatives (Izmjena / uskraćivanje izmjene upisa)
Currency
EUR
Amount Local
200
Amount Local Formatted
EUR 200.00
Frequency
Per application
Notes
Group 8 item 2.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
device-register-entry-1-to-5-products
Item
Entry in the register of medical devices, 1 to 5 products
Currency
EUR
Amount Local
800
Amount Local Formatted
EUR 800.00
Frequency
Per application
Notes
Group 8 item 3. Items 4 and 5 charge EUR 900.00 for 6 to 30 products and EUR 1,000.00 for more than 30 products.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
device-register-entry-6-to-30-products
Item
Entry in the register of medical devices, 6 to 30 products
Currency
EUR
Amount Local
900
Amount Local Formatted
EUR 900.00
Frequency
Per application
Notes
Group 8 item 4.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
device-register-entry-over-30-products
Item
Entry in the register of medical devices, more than 30 products
Currency
EUR
Amount Local
1000
Amount Local Formatted
EUR 1,000.00
Frequency
Per application
Notes
Group 8 item 5.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
device-register-change
Item
Change of an entry in the register of medical devices (Izmjena upisa u očevidnik medicinskih proizvoda)
Currency
EUR
Amount Local
300
Amount Local Formatted
EUR 300.00
Frequency
Per application
Notes
Group 8 item 6. Item 7 charges EUR 200.00 where the registration decision itself is not changed.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
device-risk-classification
Item
Risk classification of a medical device (Razvrstavanje medicinskog proizvoda s obzirom na klasu rizika)
Currency
EUR
Amount Local
1000
Amount Local Formatted
EUR 1,000.00 plus the cost of an external expert where one is engaged
Frequency
Per request
Notes
Group 8 item 8, on the manufacturer's request; item 9 charges the same amount for assigning a product to a device group on the manufacturer's enquiry. The published price is '1.000,00 € + dodatni troškovi ako je uključen vanjski stručnjak', so the expert component is dynamic and not a fixed published amount.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
srn-issue
Item
Issue of the Single Registration Number (SRN broj) by enterprise size
Currency
EUR
Amount Local
400
Amount Local Formatted
EUR 400.00 (micro), EUR 600.00 (small), EUR 800.00 (medium or large)
Frequency
Per issue
Notes
Group 8 items 22, 23 and 24 respectively.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
free-sale-certificate
Item
Free-sale certificate for one country (Potvrda o slobodnoj prodaji za jednu zemlju)
Currency
EUR
Amount Local
150
Amount Local Formatted
EUR 150.00 to EUR 380.00
Frequency
Per country and per application
Notes
Group 8 items 25 to 29 scale with the number of products: EUR 150.00 for 1 to 5, EUR 200.00 for 6 to 20, EUR 250.00 for 21 to 50, EUR 300.00 for 51 to 100 and EUR 380.00 for more than 100 products. The amount carried here is the lowest published line.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
distributor-register-entry
Item
Entry in the register of distributors (Upis / uskraćivanje upisa u registar distributera)
Currency
EUR
Amount Local
400
Amount Local Formatted
EUR 400.00 to EUR 1,050.00
Frequency
Per application
Notes
Group 8 items 30 to 42 scale with enterprise size and the number of branch offices: EUR 400.00 for a micro enterprise, up to EUR 1,050.00 for a medium or large enterprise with more than 100 branches. The amount carried here is the lowest published line; the register is the one Article 9(2) of NN 100/2018 governs.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
annual-status-maintenance-manufacturer
Item
Maintenance of medical device status for manufacturers and authorised representatives established in Croatia
Currency
EUR
Amount Local
200
Amount Local Formatted
EUR 200.00 to EUR 800.00
Frequency
Per maintenance period (period not stated in the price list)
Notes
Group 8 items 10 to 17 scale with the number of products, from EUR 200.00 for up to 10 products to EUR 800.00 for more than 1,000. Item 18 charges importers EUR 250.00. The price list footnotes this block: items 10 to 19 begin to be charged under Articles 29 and 30 of Regulation (EU) 2017/745, the EUDAMED registration duty.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
prrc-change
Item
Change of the person responsible for regulatory compliance in EUDAMED (Izmjena osobe odgovorne za usklađenost s propisima u Eudamedu)
Currency
EUR
Amount Local
100
Amount Local Formatted
EUR 100.00
Frequency
Per change
Notes
Group 8 item 19; part of the block the price list footnotes with the EUDAMED registration duty.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
conformity-assessment-derogation
Item
Derogation from the conformity assessment procedures under Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746
Currency
EUR
Amount Local
1000
Amount Local Formatted
EUR 1,000.00
Frequency
Per application
Notes
Group 8 item 69.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16
Id
market-notification-receipt-certificate
Item
Issue of the certificate of receipt of the notification of placing on the market (Izdavanje potvrde primitka obavijesti o stavljanju u promet)
Currency
EUR
Amount Local
100
Amount Local Formatted
EUR 100.00
Frequency
Per certificate
Notes
Group 8 item 71; item 72 charges EUR 70.00 to change the certificate. This is the charge for the certificate of receipt, not for the market notification itself.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Source Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Source Effective Date
2025-04-01
Verified On
2026-09-16

Notes

The HALMED price list (Cjenik usluga HALMED-a) is in force since 9 March 2024, and the amendments in force from 1 July 2024 and from 1 April 2025 are implemented in the published text; group 8 'Medicinski proizvodi' carries 76 device items.
Prices are expressed in euro excluding VAT: 'Cijene su izražene u eurima bez PDV-a.'
The two risk bands are the reporter's grouping of published line items, not a published range. The low band is the spread between the EUR 200.00 change-of-registration line and the EUR 800.00 entry in the register of medical devices for 1 to 5 products. The high band is the spread between the EUR 900.00 entry for 6 to 30 products and the EUR 1,050.00 top of the distributor-register line for a medium or large enterprise with more than 100 branches.
The tariff is not differentiated by device risk class: cost tracks the number of products registered, the size of the enterprise and the number of branches, so the bands are an approximation of scale rather than a class-based price.
Applications for group 8 services must be created through HALMED's 'Web ponude' application, through which the applicant generates the offer on which payment is made.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Cjenik usluga HALMED-a (HALMED price list), group 8 'Medicinski proizvodi' items 1-76 — in force since 9 March 2024, with the amendments in force from 1 July 2024 and 1 April 2025 implemented
Url
https://www.halmed.hr/O-HALMED-u/Usluge-i-cjenik/Cjenik-usluga-HALMED-a/
Effective Date
2025-04-01
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Croatia certifications →

Slug

croatia

Market

Croatia

Confidence

high

Schemes

Id
lvd-medical-exclusion-mdr-electrical-safety
Name
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Electrical Medical Equipment
Note
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so no separate Croatian electrical-safety certificate exists for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity. For radio equipment the same essential requirements are instead carried by the Croatian radio rule, whose Article 5(1)(1) applies the electrical-safety requirements without any voltage limitation. The Croatian transposing instrument for standalone low-voltage equipment was not retrieved, so this row is bound to the Union directive.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/35/oj
Source Binding
candidate
Id
emc-directive-disapplied-by-mdr
Name
EMC Directive disapplied where MDR fixes the same essential requirements
Category
emc
Status
Included In Medical Registration
Object
Electrical Medical Equipment
Note
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate Croatian conformity step. Where a device is also radio equipment, the Croatian radio rule (Pravilnik o radijskoj opremi, NN 49/2016, Article 5(1)(2)) applies the EMC protection requirements directly and HAKOM is the market-surveillance authority. The Croatian transposing instrument for standalone EMC equipment was not retrieved, so this row is bound to the Union directive.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/30/oj
Source Binding
candidate
Id
hakom-radio-equipment-pravilnik
Name
HAKOM radio-equipment market access (Pravilnik o radijskoj opremi, NN 49/2016)
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Note
The Pravilnik o radijskoj opremi (NN 49/2016) transposes Directive 2014/53/EU into Croatian law (Article 2) and is administered by HAKOM, defined in Article 4(1) as 'Agencija: Hrvatska regulatorna agencija za mrežne djelatnosti'. Article 5(1) sets the essential requirements — health and safety per the low-voltage rules without applying voltage limits, EMC protection, and efficient spectrum use. Article 7(1) obliges the manufacturer to register types of radio equipment within the low-compliance categories in the European Commission's central system before placing them on the market, Article 9 makes compliant equipment a condition of putting into service and use, Article 10(1) makes HAKOM the body that determines and publishes the regulated radio interfaces in Croatia, and Article 20(2) requires the EU declaration of conformity in Croatian in Latin script. There is no separate Croatian type approval; the applicant relies on the RED conformity route and must register the type where the category requires it.
Source Urls
https://narodne-novine.nn.hr/clanci/sluzbeni/2016_05_49_1322.html
Source Binding
reviewed
Id
dzm-legal-metrology-act
Name
DZM legal-metrology type examination and verification
Category
Legal Metrology
Status
Mandatory For Use Site
Object
Legal Measuring Instruments
Note
Zakon o mjeriteljstvu (NN 74/14, 111/18, 114/22) governs legal metrology in Croatia, and the tasks are performed by the Državni zavod za mjeriteljstvo (DZM) together with authorised verification bodies and authorised preparation bodies, as the DZM's legal-metrology pages set out with separate procedures for type examination (ispitivanje tipa mjerila) and verification (ovjeravanje mjerila). A device that is a legal measuring instrument (for example a sphygmomanometer or a weighing instrument used in trade or in medical practice) therefore needs its own type examination and verification; the CE mark on a medical device does not discharge that duty. The DZM page was read, but the article numbers of the Metrology Act itself were not opened, so no article is cited.
Source Urls
https://dzm.gov.hr/zakonsko-mjeriteljstvo/80
Source Binding
reviewed
Id
civil-protection-ionizing-radiation-approval
Name
Civil Protection Directorate approval for activities with ionizing-radiation sources
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Ionizing Radiation Sources And Electrical Radiation Devices
Note
An odobrenje za obavljanje djelatnosti must be obtained for the activities with ionizing-radiation sources listed in Article 14 of the Pravilnik o obavješćivanju, registriranju i odobrenjima te prometu izvorima ionizirajućeg zračenja (NN 54/18, 6/22). The Directorate's page lists the covered activities expressly including 'ELEKTRIČNI UREĐAJI KOJI PROIZVODE IONIZIRAJUĆE ZRAČENJE (rendgenski uređaji, akceleratori i slično)', so an X-ray or accelerator-based medical device is in scope even though it contains no radioactive source. The request goes to the Sektor za radiološku i nuklearnu sigurnost with the data required by Article 15(2) and the documents required by Articles 16, 17 and/or 18, the set depending on the activity; for radioactive sources Articles 19(2) and 20-23 apply. The page states that the approval is subject to administrative fees in force from 1 January 2023 but does not publish the amounts.
Source Urls
https://civilna-zastita.gov.hr/podrucja-djelovanja/radioloska-i-nuklearna-sigurnost/sluzba-za-radiolosku-sigurnost/zahtjev-za-odobrenje-za-obavljanje-djelatnosti/119
Source Binding
reviewed
Id
fzoeu-weee-producer-registration
Name
WEEE producer responsibility through the Environmental Protection and Energy Efficiency Fund
Category
Environmental And Batteries
Status
Mandatory Pre Market
Object
Electrical And Electronic Equipment
Note
Electrical and electronic equipment placed on the Croatian market carries the national WEEE producer duties, administered by the Fond za zaštitu okoliša i energetsku učinkovitost (FZOEU), which registers producers and finances the collection and treatment of waste equipment. The fund's WEEE page was retrieved but carries almost no body text, and the instrument transposing Directive 2012/19/EU with its registration thresholds and fee amounts was not retrievable this round, so this row names the authority and the duty but asserts no article and no amount.
Source Binding
unresolved

Official Sources

Authority
HAKOM — Hrvatska regulatorna agencija za mrežne djelatnosti
Topic
radio equipment: Pravilnik o radijskoj opremi (NN 49/2016), which transposes Directive 2014/53/EU
Url
https://narodne-novine.nn.hr/clanci/sluzbeni/2016_05_49_1322.html
Authority
EUR-Lex
Topic
Directive 2014/35/EU (Low Voltage Directive), Annex II medical exclusion
Url
https://eur-lex.europa.eu/eli/dir/2014/35/oj
Authority
EUR-Lex
Topic
Directive 2014/30/EU (EMC Directive), Article 2(3)
Url
https://eur-lex.europa.eu/eli/dir/2014/30/oj
Authority
Državni zavod za mjeriteljstvo (DZM)
Topic
legal metrology under the Zakon o mjeriteljstvu, type examination and verification of legal measuring instruments
Url
https://dzm.gov.hr/zakonsko-mjeriteljstvo/80
Authority
Ravnateljstvo civilne zaštite
Topic
approval for activities with ionizing-radiation sources, including electrical devices that produce ionizing radiation (NN 54/18, 6/22)
Url
https://civilna-zastita.gov.hr/podrucja-djelovanja/radioloska-i-nuklearna-sigurnost/sluzba-za-radiolosku-sigurnost/zahtjev-za-odobrenje-za-obavljanje-djelatnosti/119
Authority
Fond za zaštitu okoliša i energetsku učinkovitost (FZOEU)
Topic
waste electrical and electronic equipment: producer registration and financing of WEEE management
Url
https://www.fzoeu.hr/hr/otpadna-elektricna-i-elektronicka-oprema/9267

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Pricing

Changes after registration

Approval validity & renewal

Notified body certificate validity — maximum five years

Authority & regime

Competent authorities — Ministry of Health and HALMED

Change control

Amendment of the Croatian market notification

Relabelling or repackaging — 28 days' prior notice

Clinical investigation & performance

Clinical investigations and performance studies approved by the Ministry of Health

Device definition & scope

Croatian definitions defer to MDR/IVDR

Dossier requirements

Documents for the Croatian market notification

Economic-operator roles

Sole authorised representative required for non-EU manufacturers

Person responsible for regulatory compliance (PRRC)

Registration of manufacturers, authorised representatives and importers

Establishment, import & distribution

Distributors must register before starting wholesale or retail trade

Importers register in EUDAMED, not in the distributor register

Fees

HALMED medical-device fees (group 8)

Label, IFU & language

Croatian language for patient and lay information

Legal basis & guidance

What the implementing act does

National implementing act NN 100/2018

QMS, audit & inspection

Market surveillance by the Ministry's Pharmaceutical Inspection

Recall, FSCA & market surveillance

Field safety corrective actions reported to HALMED

Registration pathways

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

National market notification waived once the device is in EUDAMED

Reliance & recognition

Croatia approvals and evidence in other markets (0 records)

Prior approvals and evidence for Croatia (3 records)

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

FDA 510(k)/PMA

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

Review clocks

Ministry approval of clinical investigations is given by decision with no statutory period; the MDR Article 70 periods apply directly

Statutory decision periods in the implementing act

Special access & derogation

National derogation for devices without conformity assessment

Standards, testing & ancillary approvals

Harmonised standards published in the Official Journal give a presumption of conformity; no Croatian standards list exists

Submission communications & appeal

No administrative appeal; judicial review only

UDI, listing & traceability

EUDAMED modules mandatory from 28 May 2026

Legacy devices must be in EUDAMED by 28 November 2026

Vigilance & incident reporting

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

Serious incident reporting timelines

Related structured datasets

More Croatia medical device resources