Agent · helsodata-2025-327-47

EHDS artikel 47: Labelling of wellness applications

Strukturelt tre: artikkelens egne punkter, ordrett.

CELEX 32025R0327 · 2026-08-31 · Vekt 70 · minimal-risk

OpenOpen reading. No metering is planned for this class.

EHDSOffisiell kilde

Inndata

• 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)

Regeltre

1. Hvis: 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…

   Punkt 1

2. Hvis: alla(in_scope = true, punkt = 2)

   Paragraph 2 applies

   2. The label referred to in paragraph 1 shall indicate the following information:

   Punkt 2

3. Hvis: alla(in_scope = true, punkt = 3)

   Paragraph 3 applies

   (a)

   Punkt 3

4. Hvis: 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;

   Punkt 4

5. Hvis: alla(in_scope = true, punkt = 5)

   Paragraph 5 applies

   (b)

   Punkt 5

6. Hvis: alla(in_scope = true, punkt = 6)

   Paragraph 6 applies

   a reference to common specifications to demonstrate compliance;

   Punkt 6

7. Hvis: alla(in_scope = true, punkt = 7)

   Paragraph 7 applies

   (c)

   Punkt 7

8. Hvis: alla(in_scope = true, punkt = 8)

   Paragraph 8 applies

   the validity period of the label.

   Punkt 8

9. Hvis: 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).

   Punkt 9

10. Hvis: 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.

    Punkt 10

11. Hvis: alla(in_scope = true, punkt = 11)

    Paragraph 11 applies

    5. The validity of the label shall not exceed three years.

    Punkt 11

12. Hvis: 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…

    Punkt 12

13. Hvis: 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.

    Punkt 13

14. Hvis: 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.

    Punkt 14

Hvis ingen regel treffer: The article is not stated to apply, or no paragraph is selected. The agent abstains rather than guesses.

Artikkelteksten som ble lest

1. 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.
2. 22. The label referred to in paragraph 1 shall indicate the following information:
3. 3(a)
4. 4the categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;
5. 5(b)
6. 6a reference to common specifications to demonstrate compliance;
7. 7(c)
8. 8the validity period of the label.
9. 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).
10. 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.
11. 115. The validity of the label shall not exceed three years.
12. 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.
13. 137. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.
14. 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.

Ingen rådgivning. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.

Sitering: 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).