Article 34

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) · European Union

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

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.