+Article 30 4

Article 30 4

4. A manufacturer of EHR systems established outside the Union shall ensure that its authorised representative has the necessary documentation readily available in order to fulfil the tasks referred to in Article 31(2).

1. Overview

Summary	Regulation

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements
Source	Requirement

3. Related Standards

Standards
Source	Requirement

Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
EULAW -
European Regulation published on http://eur-lex.europa.eu/