Article 41

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 CE marking of conformity shall be affixed visibly, legibly and indelibly to the accompanying documents of the EHR system and, where applicable, to the packaging of the EHR system. 2. The CE marking of conformity shall be affixed before placing the EHR system on the market. 3. The CE marking of conformity shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

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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.