+Article 36 6

Article 36 6

6.   Where common specifications covering interoperability and security requirements of medical devices, in vitro diagnostic medical devices or high-risk AI systems falling under other legal acts, such as Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, affect EHR systems, the Commission shall ensure that the adoption of those common specifications is preceded by a consultation with the EHDS Board and the EDPB, as applicable.

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