+Article 31 1

Article 31 1

1. Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.

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/