art_32__para_5__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

Where an importer considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons, it shall without undue delay inform the market surveillance authorities of the Member State in which it is established, as well as the manufacturer and, where applicable, the authorised representative.

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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.