Different compliance documents have different language requirements. The AISDP itself is maintained in the provider’s working language (typically English). Instructions for Use must be translated into the official language of each deployment member state under Article 13(3)(b)(ii). The Declaration of Conformity follows member state requirements; some accept English, others require the national language. Serious incident reports follow the receiving authority’s language requirements.

Translation quality requires domain expertise across EU regulatory language, AI terminology, and the application domain. Mistranslation of a performance threshold or limitation can have compliance consequences. The workflow is: human translation by a domain-aware translator, technical review by a bilingual domain expert, and retention as a controlled document. A standardised glossary mapping key terms across deployment languages ensures consistency.

For a five-language deployment, initial translation costs typically fall between EUR 10,000 and EUR 30,000 per system, with annual maintenance of EUR 3,000 to EUR 10,000. Timeline planning allows two to four weeks for initial translation and one to two weeks for updates.

Key outputs

• Per-document-type language requirements mapped
• Domain-expert translation with technical review
• Standardised multi-language glossary
• Module 8 and Module 10 AISDP documentation