Agent · helsodata-2025-327-34
EHDS artikel 34: Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
Structural tree: the article's own paragraphs, verbatim.
CELEX 32025R0327 · 2026-08-31 · Weight 70 · minimal-risk
OpenOpen reading. No metering is planned for this class.
- What this page is
- Agent, EHDS artikel 34
- Checked against the official source
- 2026-08-31Current
- Responsible publisher
- ExploreWorld Legal, editorial deskLiability position
Short answer
What does EHDS Article 34 require, and what outcome does the rule tree give?
EHDS Article 34 is tested here by a deterministic rule tree of 7 rules, built from the article's own conditions. The tree reads your facts and names the outcome that applies, starting with Paragraph 1 applies, carrying paragraph citation, content hash and read date 2026-08-31 against CELEX 32025R0327. The outcome is a machine classification, not a compliance decision.
EHDS Article 34Checked against the publisher 2026-08-31Official text
- Paragraph 1 applies. 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:
- Paragraph 2 applies. (a)
- Paragraph 3 applies. make an EHR system available on the market under their own name or trademark;
A source reference, not legal advice.
Jurisdiction
The same agent, read through one country's lens.
Inputs
- in_scopeThe article applies to the situationboolean
- punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7)
Rule tree
If: alla(in_scope = true, punkt = 1)
Paragraph 1 applies
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:
Paragraph 1
If: alla(in_scope = true, punkt = 2)
Paragraph 2 applies
(a)
Paragraph 2
If: alla(in_scope = true, punkt = 3)
Paragraph 3 applies
make an EHR system available on the market under their own name or trademark;
Paragraph 3
If: alla(in_scope = true, punkt = 4)
Paragraph 4 applies
(b)
Paragraph 4
If: alla(in_scope = true, punkt = 5)
Paragraph 5 applies
modify an EHR system already placed on the market in such a way that conformity with the applicable requirements might be affected; or
Paragraph 5
If: alla(in_scope = true, punkt = 6)
Paragraph 6 applies
(c)
Paragraph 6
If: alla(in_scope = true, punkt = 7)
Paragraph 7 applies
modify an EHR system in such a way that it leads to changes in the intended purpose declared by the manufacturer.
Paragraph 7
If no rule matches: The article is not stated to apply, or no paragraph is selected. The agent abstains rather than guesses.
The article text as read
- 1An 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:
- 2(a)
- 3make an EHR system available on the market under their own name or trademark;
- 4(b)
- 5modify an EHR system already placed on the market in such a way that conformity with the applicable requirements might be affected; or
- 6(c)
- 7modify an EHR system in such a way that it leads to changes in the intended purpose declared by the manufacturer.
Lineage
Interface
Hashes
Artefacts
No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.
Citation: 32025R0327 art. 34, Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-34 (hämtad 2026-08-31, bevis sha256:5c013b33ae7eca0f, bygge legal-2026-08-25).