+Article 39 2

Article 39 2

2.   Where an EHR system is subject to other Union legal acts in respect of aspects not covered by this Regulation, which also require an EU declaration of conformity by the manufacturer in which it is stated that the fulfilment of the requirements of those legal acts has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union legal acts applicable to the EHR system. That EU declaration of conformity shall contain all the information required for the identification of the Union legal acts to which it relates.

1. Vue d’ensemble

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Intitulé Réglementation

1.1 Références

1.2 Exigences identifiées

1.3 Normes associées

2. Exigences identifiées

Exigences
Source Exigence

3. Normes associées

Normes
Source Exigence