art_44__para_10

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

10. In the event of incidents putting at risk patient safety or information security, the market surveillance authorities may take immediate action and require the manufacturer of the EHR system concerned, its authorised representative and other economic operators, if applicable, to take immediate corrective action.

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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.