+Article 39 5

Article 39 5

5.   By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the harmonised software components of the EHR system with the requirements laid down in this Regulation when it is placed on the market or put into service.

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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