+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. Pregled

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Naslov Regulativa

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve
Vir Zahteva

3. Povezani standardi

Standardi
Vir Zahteva