EU regulatory register · EHDS
Article 34Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
CELEX 32025R0327 · Read on 2026-08-31
Short answer
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:
Verbatim from the article. Source: NovaCopilot · https://legal.exploreworldai.com/eu/rattsakter/helsodata-2025-327/artikel-34 · Short answer as data · Official text
Official text
Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.
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:
(a)
make an EHR system available on the market under their own name or trademark;
(b)
modify an EHR system already placed on the market in such a way that conformity with the applicable requirements might be affected; or
(c)
modify an EHR system in such a way that it leads to changes in the intended purpose declared by the manufacturer.
Follow-up questions
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