MDR & IVDR national implementation: Croatia

Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Devices Regulation (IVDR) 2017/746 are mainly the Act on the Implementation of MDR/IVDR and the Ordinance on Essential Requirements. Below you can find an overview of the most important points.
Notification of Medical Devices and IVDs
The Croatian Competent Authorities have two registers for economic operators as set in the Ordinance on essential requirements (Halmed, 2013):

  • A register for distributors (Art. 9);
  • A register for Croatian manufacturers and Croatian Authorized Representatives (Art. 10);

Moreover, the following devices should be notified to the Croatian Competent Authority (Art. 41 Ordinance) until EUDAMED is fully functional and if not already registered on EUDAMED:

  • Class IIa;
  • Class IIb;
  • Class III;
  • IVD (all classes);
  • Active Implantable Medical Devices (AIMD);

This notification should be submitted by the legal and natural persons placing the abovementioned devices on the Croatian market.
Reprocessing of Single Use devices
Only MDR/IVDR complaint single-use medical devices may be reprocessed and then used within Croatian health institutions (Art. 13). The health-institution shall provide the relevant information to the patient.
Clinical evaluation and clinical trials
The Ministry may grant authorization to conduct a clinical trial or a performance study to a medical device or an in vitro diagnostic medical device following a positive opinion by the Central Ethics Committee.
Language requirements and label requirements
The documentation intended for patients and lay persons must be in Croatian language. HALMED, Croatian Competent Authority, clarified that labels may be in English only if there is an assurance that the users would readily understand English language. In any other case labels should be in Croatian or bilingual. Furthermore, translation to Croatian would need to be provided if requested by the user. Also, the manufacturer’s website may display its labels voluntarily.

In contrast, documentation intended for the Competent Authority or to be exclusively used for healthcare professionals may be in Croatian or English language (Art. 30).
Finally, the following fines are established under the Croatian law (Halmed, 2018):

  • A fine of HRK 100,000.00 to HRK 700,000.00 for legal persons that, among others:
    • Put a non-conform device on the market;
    • Put into service a device not complying with MDR/IVDR general safety and performance requirements;
    • Do not implement or maintain a risk management system;
    • Fail to carry out a clinical evaluation/performance evaluation as per MDR/IVDR requirements;
    • Does not provide an implant card with the information required;
    • Does not add importer’s details to the device;
  • A fine of HRK 50,000.00 to HRK 200,000.00 for legal persons that, among others:
    • Do not make available a copy of an EU Declaration of Conformity (DoC);
    • Uses misleading claims on device’s labelling;
    • Does not ensure that the necessary labelling information is translated in Croatian;
    • For manufacturers of custom-made devices: Do not draw up or regularly update the documentation or do not allow the Competent Authority to consult the documentation;
    • Manufacturers that do not make available their technical documentation, EU DoC or appropriate Certificates;
  • Other fines are also applicable to importers, distributors and notified bodies.


Oh! It looks like you do not have access to this page.
Find the membership plan that suits you, and within a few minutes you are good to go.
Are you a member already? Log in here.