art_39__para_3

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) · European Union

3. The EU declaration of conformity shall contain the information set out in Annex IV and shall be translated into one or more official Union languages determined by the Member States in which the EHR system is made available.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.