+Article 36 5

Article 36 5

5.   Where common specifications covering interoperability and security requirements of EHR systems affect 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, the adoption of those common specifications may be preceded by a consultation with the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board established by Article 65 of Regulation (EU) 2024/1689 and the European Data Protection Board (EDPB), as applicable.

1. Pregled

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Naslov Regulativa

1.1 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi
Izvor Zahtjev

3. Povezani standardi

Standardi
Izvor Zahtjev