Agent · helsodata-2025-327-47
EHDS artikel 47: Labelling of wellness applications
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 47
- Checked against the official source
- 2026-08-31Current
- Responsible publisher
- ExploreWorld Legal, editorial deskLiability position
Short answer
What does EHDS Article 47 require, and what outcome does the rule tree give?
EHDS Article 47 is tested here by a deterministic rule tree of 14 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 47Checked against the publisher 2026-08-31Official text
- Paragraph 1 applies. 1. Where a manufacturer of a wellness application claims interoperability with an EHR system in relation to the harmonised software components of EHR systems and therefore compliance with the common specifications referred to in Article 36 and essential requirements laid down in Annex II, such wellness application shall be accompanied by a label, clearly indicating its compliance with those specifications and require…
- Paragraph 2 applies. 2. The label referred to in paragraph 1 shall indicate the following information:
- Paragraph 3 applies. (a)
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 | 8 | 9 | 10 | 11 | 12 | 13 | 14)
Rule tree
If: alla(in_scope = true, punkt = 1)
Paragraph 1 applies
1. Where a manufacturer of a wellness application claims interoperability with an EHR system in relation to the harmonised software components of EHR systems and therefore compliance with the common specifications referred to in Article 36 and essential requirements laid down in Annex II, such wellness application shall be accompanied by a label, clearly indicating its compliance with those specifications and require…
Paragraph 1
If: alla(in_scope = true, punkt = 2)
Paragraph 2 applies
2. The label referred to in paragraph 1 shall indicate the following information:
Paragraph 2
If: alla(in_scope = true, punkt = 3)
Paragraph 3 applies
(a)
Paragraph 3
If: alla(in_scope = true, punkt = 4)
Paragraph 4 applies
the categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;
Paragraph 4
If: alla(in_scope = true, punkt = 5)
Paragraph 5 applies
(b)
Paragraph 5
If: alla(in_scope = true, punkt = 6)
Paragraph 6 applies
a reference to common specifications to demonstrate compliance;
Paragraph 6
If: alla(in_scope = true, punkt = 7)
Paragraph 7 applies
(c)
Paragraph 7
If: alla(in_scope = true, punkt = 8)
Paragraph 8 applies
the validity period of the label.
Paragraph 8
If: alla(in_scope = true, punkt = 9)
Paragraph 9 applies
3. The Commission shall, by means of implementing acts, determine the format and content of the label referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Paragraph 9
If: alla(in_scope = true, punkt = 10)
Paragraph 10 applies
4. The label shall be drawn-up in one or more official languages of the Union or in an easily understandable language determined by the Member State in which the wellness application is placed on the market or put into service.
Paragraph 10
If: alla(in_scope = true, punkt = 11)
Paragraph 11 applies
5. The validity of the label shall not exceed three years.
Paragraph 11
If: alla(in_scope = true, punkt = 12)
Paragraph 12 applies
6. If the wellness application is an integral part of a device or is embedded in a device after it has been put into service, the accompanying label shall be shown in the application itself or placed on that device. Where the wellness application consists only of software, the label shall have a digital format and shall be shown in the application itself. Two-dimensional (2D) barcodes may also be used to display the…
Paragraph 12
If: alla(in_scope = true, punkt = 13)
Paragraph 13 applies
7. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.
Paragraph 13
If: alla(in_scope = true, punkt = 14)
Paragraph 14 applies
8. Each supplier of a wellness application for which a label has been issued shall ensure that the wellness application that is placed on the market or put into service is accompanied by the label for each individual unit, free of charge.
Paragraph 14
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
- 11. Where a manufacturer of a wellness application claims interoperability with an EHR system in relation to the harmonised software components of EHR systems and therefore compliance with the common specifications referred to in Article 36 and essential requirements laid down in Annex II, such wellness application shall be accompanied by a label, clearly indicating its compliance with those specifications and requirements. That label shall be issued by the manufacturer of the wellness application.
- 22. The label referred to in paragraph 1 shall indicate the following information:
- 3(a)
- 4the categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;
- 5(b)
- 6a reference to common specifications to demonstrate compliance;
- 7(c)
- 8the validity period of the label.
- 93. The Commission shall, by means of implementing acts, determine the format and content of the label referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 104. The label shall be drawn-up in one or more official languages of the Union or in an easily understandable language determined by the Member State in which the wellness application is placed on the market or put into service.
- 115. The validity of the label shall not exceed three years.
- 126. If the wellness application is an integral part of a device or is embedded in a device after it has been put into service, the accompanying label shall be shown in the application itself or placed on that device. Where the wellness application consists only of software, the label shall have a digital format and shall be shown in the application itself. Two-dimensional (2D) barcodes may also be used to display the label.
- 137. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.
- 148. Each supplier of a wellness application for which a label has been issued shall ensure that the wellness application that is placed on the market or put into service is accompanied by the label for each individual unit, free of charge.
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Artefacts
No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.
Citation: 32025R0327 art. 47, Labelling of wellness applications. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-47 (hämtad 2026-08-31, bevis sha256:2738c535cad26962, bygge legal-2026-08-25).