Article 41

The CE marking of conformity must be visibly, legibly, and indelibly affixed to the accompanying documents and, if applicable, the packaging of the EHR system before it is placed on the market. It follows the general principles outlined in Article 30 of Regulation (EC) No 765/2008.

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.

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