(j)

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

inform the distributors of their EHR systems and, where applicable, the authorised representative, importers and users of the non-conformity and of any corrective action, recall or withdrawal of those EHR systems;

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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.