EHDS, Article 41, SE

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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