EU regulatory register · EHDS
Article 41CE marking of conformity
CELEX 32025R0327 · Read on 2026-08-31
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.
The text is quoted from the official source and is not legal advice. A national court reads the language version that binds in its jurisdiction.
Verifiable trust signals
- Six fixed blocks, one source per line
- No sentence written by a language model
- Engine version and read date on every answer
- No customer data, no documents, no advice
- Model card and audit published under the EU AI Act