Agent · helsodata-2025-327-27
EHDS artikel 27: Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
Strukturelt tre: artikkelens egne punkter, ordrett.
CELEX 32025R0327 · 2026-08-31 · Vekt 70 · minimal-risk
OpenOpen reading. No metering is planned for this class.
- Hva siden er
- Agent, EHDS artikel 27
- Lest mot offisiell kilde
- 2026-08-31Fersk
- Ansvarlig utgiver
- ExploreWorld Legal, redaksjonenAnsvarsposisjon
Kort svar
What does EHDS Article 27 require, and what outcome does the rule tree give?
EHDS Article 27 is tested here by a deterministic rule tree of 2 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 27Lest mot utgiveren 2026-08-31Offisiell tekst
- Paragraph 1 applies. 1. Manufacturers of medical devices or in vitro diagnostic medical devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745 and Article 2, point (2), of Regulation (EU) 2017/746, respectively, that claim interoperability of those medical devices or in vitro diagnostic medical devices with the harmonised software components of EHR systems shall prove compliance with the essential requirements on the Eu…
- Paragraph 2 applies. 2. Providers of AI systems considered to be high-risk in accordance with Article 6 of Regulation (EU) 2024/1689 (the ‘high-risk AI system’) and which do not fall within the scope of Regulation (EU) 2017/745 or (EU) 2017/746, that claim interoperability of those high-risk AI systems with the harmonised software components of EHR systems, shall prove compliance with the essential requirements on the European interopera…
En kildehenvisning, ikke juridisk rådgivning.
Jurisdiksjon
Samme agent, lest med ett lands øyne.
Inndata
- in_scopeThe article applies to the situationboolean
- punktParagraph of the articleenum (1 | 2)
Regeltre
Hvis: alla(in_scope = true, punkt = 1)
Paragraph 1 applies
1. Manufacturers of medical devices or in vitro diagnostic medical devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745 and Article 2, point (2), of Regulation (EU) 2017/746, respectively, that claim interoperability of those medical devices or in vitro diagnostic medical devices with the harmonised software components of EHR systems shall prove compliance with the essential requirements on the Eu…
Punkt 1
Hvis: alla(in_scope = true, punkt = 2)
Paragraph 2 applies
2. Providers of AI systems considered to be high-risk in accordance with Article 6 of Regulation (EU) 2024/1689 (the ‘high-risk AI system’) and which do not fall within the scope of Regulation (EU) 2017/745 or (EU) 2017/746, that claim interoperability of those high-risk AI systems with the harmonised software components of EHR systems, shall prove compliance with the essential requirements on the European interopera…
Punkt 2
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
- 11. Manufacturers of medical devices or in vitro diagnostic medical devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745 and Article 2, point (2), of Regulation (EU) 2017/746, respectively, that claim interoperability of those medical devices or in vitro diagnostic medical devices with the harmonised software components of EHR systems shall prove compliance with the essential requirements on the European interoperability software component for EHR systems and the European logging software component for EHR systems, laid down in Section 2 of Annex II to this Regulation. Article 36 of this Regulation shall apply to those medical devices and in vitro diagnostic medical devices.
- 22. Providers of AI systems considered to be high-risk in accordance with Article 6 of Regulation (EU) 2024/1689 (the ‘high-risk AI system’) and which do not fall within the scope of Regulation (EU) 2017/745 or (EU) 2017/746, that claim interoperability of those high-risk AI systems with the harmonised software components of EHR systems, shall prove compliance with the essential requirements on the European interoperability software component for EHR systems and the European logging software component for EHR systems, as laid down in Section 2 of Annex II to this Regulation. Article 36 of this Regulation shall apply to those high-risk AI systems.
Opphav
Grensesnitt
Hasher
Artefakter
Ingen rådgivning. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.
Sitering: 32025R0327 art. 27, Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-27 (hämtad 2026-08-31, bevis sha256:8f5cb5371ebdd805, bygge legal-2026-08-25).