EU regulatory register · EHDS
Article 41CE marking of conformity
CELEX 32025R0327 · Read on 2026-08-31
Short answer
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.
Verbatim from the article. Source: NovaCopilot · https://legal.exploreworldai.com/eu/rattsakter/helsodata-2025-327/artikel-41 · Short answer as data · Official text
Official text
Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.
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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