art_44__para_7__para

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

The reporting required pursuant to the first subparagraph of this paragraph shall be carried out, without prejudice to incident notification requirements under Directive (EU) 2022/2555, immediately after the manufacturer has established a causal link between the EHR system and the serious incident or the reasonable likelihood of such a link and, in any event, not later than three days after the manufacturer becomes aware of the serious incident involving the EHR system.

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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.