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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)

article  41

CELEX:  32025R0327

CE marking of conformity
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.