Agent · helsodata-2025-327-49
EHDS artikel 49: EU database for registration of EHR systems and 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 49
- Checked against the official source
- 2026-08-31Current
- Responsible publisher
- ExploreWorld Legal, editorial deskLiability position
Short answer
What does EHDS Article 49 require, and what outcome does the rule tree give?
EHDS Article 49 is tested here by a deterministic rule tree of 4 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 49Checked against the publisher 2026-08-31Official text
- Paragraph 1 applies. 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’).
- 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…
- 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.
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)
Rule tree
If: alla(in_scope = true, punkt = 1)
Paragraph 1 applies
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’).
Paragraph 1
If: 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…
Paragraph 2
If: 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.
Paragraph 3
If: alla(in_scope = true, punkt = 4)
Paragraph 4 applies
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.
Paragraph 4
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. 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’).
- 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.
- 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.
- 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.
Lineage
Interface
Hashes
Artefacts
No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.
Citation: 32025R0327 art. 49, EU database for registration of EHR systems and wellness applications. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-49 (hämtad 2026-08-31, bevis sha256:41054c4d57e43c0c, bygge legal-2026-08-25).