+Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
---+Article 34 (a)
---+Article 34 (b)
---+Article 34 (c)

Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals

An importer, distributor or user shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 30 where they:

1. Overview

Summary	Regulation
Article 34 (a)	make an EHR system available on the market under their own name or trademark;
Article 34 (b)	modify an EHR system already placed on the market in such a way that conformity with the applicable requirements might be affected; or
Article 34 (c)	modify an EHR system in such a way that it leads to changes in the intended purpose declared by the manufacturer.

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 -
EN: Legal acts of the European Union from EUR-Lex, https://eur-lex.europa.eu/. © European Union. Re-use is authorised by Decision 2011/833/EU, provided the source is acknowledged; the consolidated texts are licensed under CC BY 4.0 (EUR-Lex legal notice). Divided into sections and converted into the GRCA format, the wording unchanged. Only the legislation published in the Official Journal of the European Union is deemed authentic.

DE: Rechtsakte der Europäischen Union aus EUR-Lex, https://eur-lex.europa.eu/. © Europäische Union. Weiterverwendung nach Beschluss 2011/833/EU mit Quellenangabe gestattet; die konsolidierten Fassungen stehen unter CC BY 4.0 (Rechtlicher Hinweis von EUR-Lex). In Abschnitte aufgeteilt und in das GRCA-Format umgewandelt, der Wortlaut unverändert. Verbindlich sind allein die im Amtsblatt der Europäischen Union veröffentlichten Rechtsakte.