Translate Instructions for Use into Serbian
ALIMS-compliant IFU translations with dual-script management for the Serbian market
Serbia is a dynamically growing medical device market with a volume of approximately 1.5 billion euros and annual growth of about 8 percent. As an EU accession candidate, Serbia is progressively harmonizing its regulations with European standards, making the market increasingly attractive and accessible for international manufacturers. Complete and standards-compliant translation of instructions for use into Serbian is a fundamental prerequisite for product registration and market access.
ALIMS (Agency for Medicines and Medical Devices of Serbia) is the competent national authority for the registration and supervision of medical devices. ALIMS increasingly aligns with the requirements of EU MDR 2017/745, though national particularities persist. Documentation must be available in Serbian, and ALIMS expects Cyrillic script for official registration documents.
Serbia's outstanding linguistic characteristic is its globally unique digraphia: Serbian is written in both Cyrillic and Latin script, and both systems are used with equal standing in everyday life. This situation requires a strategic decision about the target script for IFU translations — or parallel creation in both systems. Conversion between Cyrillic and Latin follows a consistent 1:1 mapping, yet handling mixed-language elements such as product names, international abbreviations, and chemical designations requires clear typographic rules.
Grammatically, Serbian is a South Slavic language with a seven-case system (including the vocative, which has been reduced in many Slavic languages), three genders, and a verbal aspect system (perfective/imperfective). In procedural instructions, aspect determines whether an action is to be understood as one-time or repeated — a distinction critical for user safety. Additionally, translators must consistently choose and maintain either the Ekavian or Ijekavian variant.
manualworks provides a comprehensive solution for Serbian IFU translations. The platform supports parallel creation in Cyrillic and Latin script, validates consistent script and variant usage, checks case correctness, and ensures aspect-appropriate verb usage in procedural instructions. For manufacturers serving the Western Balkans market, manualworks also enables coordinated translation into Serbian, Croatian, and Bosnian with controlled terminology divergence.
Frequently Asked Questions
In which script should a Serbian IFU be written — Cyrillic or Latin?+
Serbia is the only country in the world where two complete alphabets — Cyrillic and Latin — are used interchangeably and with equal standing in everyday life. According to the Serbian constitution, Cyrillic is the official script, and Cyrillic is expected for governmental documents and official registration submissions. In practice, however, many professional fields including medical technology also use the Latin script. manualworks supports both writing systems and can deliver translations in Cyrillic, Latin, or both scripts simultaneously.
Which authority regulates medical devices in Serbia?+
ALIMS (Agency for Medicines and Medical Devices of Serbia) is the competent authority for the registration and supervision of medical devices in Serbia. As an EU accession candidate, Serbia is progressively harmonizing its regulations with EU MDR 2017/745. ALIMS requires complete documentation in Serbian. manualworks accounts for both current Serbian requirements and the ongoing alignment with EU standards.