art_30__para_4

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

4. A manufacturer of EHR systems established outside the Union shall ensure that its authorised representative has the necessary documentation readily available in order to fulfil the tasks referred to in Article 31(2).

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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.