art_39__para_5

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

5. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the harmonised software components of the EHR system with the requirements laid down in this Regulation when it is placed on the market or put into service.

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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.