+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. Overview

,

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements

3. Related Standards

Standards
  • Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
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