Agent · helsodata-2025-327-46

EHDS artikel 46: Union safeguard procedure

What is an agent? Agents execute decisions.

Structural tree: the article's own paragraphs, verbatim.

Also searched as: Regulation (EU) 2025/327 article 46

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

OpenOpen reading. No metering is planned for this class.

EHDSOfficial source

Inputs

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

Rule tree

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

   Paragraph 1 applies

   1. Where, under Article 44(2) and Article 45(3), objections are raised against a national measure taken by a market surveillance authority, or where the Commission considers a national measure to be contrary to Union law, the Commission shall without delay enter into consultations with that market surveillance authority and the relevant economic operators and shall evaluate the national measure concerned. On the basi…

   Paragraph 1

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

   Paragraph 2 applies

   2. If the national measure referred to in paragraph 1 is considered justified by the Commission, all Member States concerned shall take the necessary measures to ensure that the non-compliant EHR system is withdrawn from their market, and shall inform the Commission accordingly.

   Paragraph 2

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

   Paragraph 3 applies

   If the national measure referred to in paragraph 1 is considered unjustified by the Commission, the Member State concerned shall revoke that measure.

   Paragraph 3

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

1. 11. Where, under Article 44(2) and Article 45(3), objections are raised against a national measure taken by a market surveillance authority, or where the Commission considers a national measure to be contrary to Union law, the Commission shall without delay enter into consultations with that market surveillance authority and the relevant economic operators and shall evaluate the national measure concerned. On the basis of the results of that evaluation, the Commission shall adopt an implementing decision determining whether the national measure is justified. That implementing decision shall be adopted in accordance with the examination procedure referred to in Article 98(2). The Commission shall address its implementing decision to all Member States and shall immediately communicate it to them and to the relevant economic operators.
2. 22. If the national measure referred to in paragraph 1 is considered justified by the Commission, all Member States concerned shall take the necessary measures to ensure that the non-compliant EHR system is withdrawn from their market, and shall inform the Commission accordingly.
3. 3If the national measure referred to in paragraph 1 is considered unjustified by the Commission, the Member State concerned shall revoke that measure.

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

Citation: 32025R0327 art. 46, Union safeguard procedure. NovaCopilot, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-46 (hämtad 2026-08-31, bevis sha256:fb0242038580aef5, bygge legal-2026-11-02).