Agent · helsodata-2025-327-49

EHDS artikel 49: EU database for registration of EHR systems and wellness applications

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Søkes også som: forordning (EU) 2025/327 artikkel 49

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

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EHDSOffisiell kilde

Inndata

• in_scopeThe article applies to the situationboolean
• punktParagraph of the articleenum (1 | 2 | 3 | 4)

Regeltre

1. Hvis: alla(in_scope = true, punkt = 1)

   Paragraph 1 addressed to the Commission, no direct obligation for businesses

   1. The Commission shall establish and maintain a publicly available EU database with data on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 39 and wellness applications for which a label has been issued pursuant to Article 47 (the ‘EU database for registration of EHR systems and wellness applications’).

   Punkt 1

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

   Paragraph 2 applies

   2. Before placing on the market or putting into service an EHR system referred to in Article 26 or a wellness application referred to in Article 47, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall enter the required data as referred to in paragraph 4 of this Article into the EU database for registration of EHR systems and wellness applications, inc…

   Punkt 2

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

   Paragraph 3 applies

   3. Medical devices, in vitro diagnostic medical devices or high-risk AI systems referred to in Article 27(1) and (2) of this Regulation shall also be registered in the databases established pursuant to Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, as applicable. In such cases, the data to be entered shall also be forwarded to the EU database for registration of EHR systems and wellness applications.

   Punkt 3

4. Hvis: alla(in_scope = true, punkt = 4)

   Paragraph 4 addressed to the Commission, no direct obligation for businesses

   4. The Commission is empowered to adopt delegated acts in accordance with Article 97 to supplement this Regulation by determining the list of required data to be entered into the EU database for registration of EHR systems and wellness applications by the manufacturers of EHR systems and wellness applications pursuant to paragraph 2 of this Article.

   Punkt 4

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. The Commission shall establish and maintain a publicly available EU database with data on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 39 and wellness applications for which a label has been issued pursuant to Article 47 (the ‘EU database for registration of EHR systems and wellness applications’).
2. 22. Before placing on the market or putting into service an EHR system referred to in Article 26 or a wellness application referred to in Article 47, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall enter the required data as referred to in paragraph 4 of this Article into the EU database for registration of EHR systems and wellness applications, including, in the case of EHR systems, the results of the assessment referred to in Article 40.
3. 33. Medical devices, in vitro diagnostic medical devices or high-risk AI systems referred to in Article 27(1) and (2) of this Regulation shall also be registered in the databases established pursuant to Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, as applicable. In such cases, the data to be entered shall also be forwarded to the EU database for registration of EHR systems and wellness applications.
4. 44. The Commission is empowered to adopt delegated acts in accordance with Article 97 to supplement this Regulation by determining the list of required data to be entered into the EU database for registration of EHR systems and wellness applications by the manufacturers of EHR systems and wellness applications pursuant to paragraph 2 of this Article.

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

Sitering: 32025R0327 art. 49, EU database for registration of EHR systems and wellness applications. NovaCopilot, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-49 (hämtad 2026-08-31, bevis sha256:fb78449e450e7df7, bygge legal-2026-11-02).