art_39__para_1

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

1. The EU declaration of conformity referred to in Article 30(1), point (e), shall state that the manufacturer of an EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.

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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.