Article 41

CE marking of conformity

In short: The CE marking of conformity shall be affixed to the EHR System documentation before placing it on the market.

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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