Agent · helsodata-2025-327-27

EHDS artikel 27: Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems

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 27
Checked against the official source: 2026-08-31Current
Responsible publisher: ExploreWorld Legal, editorial deskLiability position

Short answer

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 27Checked against the publisher 2026-08-31Official text

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…

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)

Rule tree

If: 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…
Paragraph 1
If: 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…
Paragraph 2

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. 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.

Lineage

treatyTFEU art. 288 (förordning)

act32025R0327

chapter—

article27

paragraphs2

jurisdictionEuropean Union (EU)

supervisor—

national—

Interface

callhttps://legal.exploreworldai.com/api/public/v1/agents/helsodata-2025-327-27/run

methodGET

outputmatched, outcome, trace, missing, hash

Quota60 anrop per minut och adress, utan nyckel

stabilityRegelträdet versioneras. En ändring byter artefakthash, aldrig adress.

Hashes

textsha256:b706eb154292f1b47d809bad4130d4eadb3f98353a20935dbb85e37d5d315382

scriptsha256:71b705d50224682d478a287a3baf2101b486a41207420479974bdc39dcfaf0a3

enginesha256:0a4bd50d21f8ec9be383fc091511008b76ad61909cbfb674eab56fe567fbd7a0

agentsha256:37ddf06dab5bbd0b157aa5af97b1ff0891a858af1b5a6c8e0fda73c3090b3546

versionagent-engine-1+legal-2026-08-25 / 37ddf06dab5bbd0b

Artefacts

No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.

Citation: 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).