MDR Language Requirements in Croatia
The EU-Medical Device Regulation MDR 2017/745 is applicable to all medical devices that are marketed or distributed in EU-Member States, resulting in an impact and an increase in translation needs on all medical device manufacturers, since there a total of 24 official languages. The Member State determines the languages accepted.
In Croatia the Medical Devices Act was originally enacted in 2013 (Official Gazette, no. 76/13) and is still in force in Croatia. However, since the adoption of the EU Medical Devices Regulations in 2017, the Act has undergone several amendments to bring it in line with the new requirements.
The most recent amendment to the Act was the Act on the Implementation of Medical Devices Regulation (EU) 2017/745 and In Vitro Medical Device Regulation (EU) 2017/746, which was published in the Official Gazette No. 100/18. This Act serves to transpose the provisions of the EU Medical Devices Regulations into national law, ensuring that medical devices placed on the Croatian market comply with the new regulations.
The competent authority is the Agency for Medicinal Products and Medical Devices of Croatia HALMED.
Índice de contenidos
Index of contents
Index du contenu
- Language Requirements for Labeling and Instructions for Use (IFUs)
- Language Requirements for the EU Declaration of Conformity
- Language Requirements for the Implant Card
- Language Requirements for the Field Safety Notice
- What other Language Requirements exist in Croatia?
- What are the consequences of non-compliance?
According to the Croatian Implementation Act all information intended for patients is to be presented in the national language:
“Information and documentation used in the implementation of the regulations from Article 2 of this Act, which are intended for patients and lay persons, must be in the Croatian language.” – Art. 30(1), Gazette No. 100/18
We can therefore understand that the labeling and the IFU must be translated into Croatian if e. g. you are a foreign medical device manufacturer. Croatian legislation differentiates the language requirements between lay person and healthcare professionals.
Let’s take a look into the next paragraph of the Croatian Medical Device Act to understand what to do with the Declaration of conformity.
“Data and documentation used in the implementation of the regulations from Article 2 of this Act, and intended for the competent authorities or exclusively for use in the performance of healthcare activities, may be in Croatian and/or English.” – Art. 30(2), Gazette No. 100/18
The declaration of conformity (DoC) is required to ensure traceability and to demonstrate that the device has been properly evaluated and meets the necessary safety and performance requirements before it is placed on the market.
In Croatia this has to be submitted to the competent authority HALMED and thus, may be accepted and/or in English. To ensure compliance with HALMED's exact requirements, we recommend contacting them directly.
The MDR requires that implantable medical devices must be accompanied by an implant card and that it must be provided to the patient free of charge. The implant card is typically given to the patient after the implantation procedure and must contain specific details about the implanted product, such as its name, model, serial number, and the name of the manufacturer.
Since this is undoubtedly “information intended for patients” as specified in Article 30(1) of the Gazette No. 100/18, this information needs to be provided in Croatian.
The field safety notice (FSN) must be sent out by manufacturers in the event of adverse effects, which include (among others): “defect, malfunctioning, deterioration of characteristics or performance […] in accordance with manufacturer’s instructions”.
The Croatian Ordinance on Monitoring Adverse Incidents Related to Medical Devices states:
“The manufacturer is obliged to submit the original of field safety notice, signed by the manufacturer’s qualified person in the Croatian language.” – Art. 21(2), Official Gazette No. 125/13
In addition, the manufacturer “is obliged to submit the field safety notice also to the notified body that performed the conformity assessment” (Art. 20(5) Official Gazette, no. 125/13). This may result in further translation needs for the FSN, depending on the accepted languages by the notified body.
It is important to be in close contact with your notified body to ensure that technical documentation and all necessary information which is to be presented to HALMED to register and classify the medical device comply with the language requirements.
According to the Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices, the Croatian language is mandatory for the application for risk classification, registration of medical device manufacturers as well as the application of registration of a medical device (Art. 9(2), Art. 11(2) and Art. 35(2), Gazette, No. 84/13).
Further, it states:
“Together with the application referred to in Article 35 of this Ordinance, the applicant shall provide the label and the instructions for use in the Croatian language and, in the case of a device manufactured by a foreign manufacturer, the original label and the instructions for use in English, if applicable” – Art. 36, Gazette 84/13
To ensure “accurate” translations set out by the EU-MDR and national legislation, medical device manufacturers, distributors and importers should consider using ISO 13485 certified language providers. Otherwise, they may face fines up to 26,000€, according to the Act on the Implementation of Medical Devices:
“A fine in the amount of HRK 50,000.00 to HRK 200,000.00 shall be imposed on a legal person for a misdemeanor if: 8) a manufacturer, does not ensure that the medical product is accompanied by the information […] in the Croatian language.” – Art. 32(1), Gazette No. 100/18
In summary, the implementation of the MDR (EU) 2017/745 and (EU) 2017/746, has changed the language requirements for medical devices in Croatia. All information intended for patients, such as labeling, instructions for use, implant cards, and field safety notices, must be provided in Croatian, while certain documents for competent authorities or professional users can be submitted in Croatian and/or English. Manufacturers should work closely with their notified body and consider using ISO 13485 certified language providers to avoid potential fines and increase patient safety.
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Alejandra Keller is a German and Spanish native speaker with a high level of proficiency in English. She holds a translation degree from the University of Heidelberg and has lived and studied in Germany, the United States, Ireland, Spain and Peru. With a strong passion for international communication, she is currently working as Project Manager at AbroadLink.