Agent · helsodata-2025-327-36

EHDS artikel 36: Common specifications

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Søkes også som: forordning (EU) 2025/327 artikkel 36

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 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14)

Regeltre

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

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

   1. By 26 March 2027, the Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements laid down in Annex II, including a common template and a time limit for implementing those common specifications. Where relevant, those common specifications shall take into account the specificities of medical devices and high-risk AI systems referred to in Article 27(1) and…

   Punkt 1

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

   Paragraph 2 applies

   2. The common specifications referred to in paragraph 1 shall include the following information and elements:

   Punkt 2

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

   Paragraph 3 applies

   (a)

   Punkt 3

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

   Paragraph 4 applies

   their scope;

   Punkt 4

5. Hvis: alla(in_scope = true, punkt = 5)

   Paragraph 5 applies

   (b)

   Punkt 5

6. Hvis: alla(in_scope = true, punkt = 6)

   Paragraph 6 applies

   their applicability to different categories of EHR systems or functions included in them;

   Punkt 6

7. Hvis: alla(in_scope = true, punkt = 7)

   Paragraph 7 applies

   (c)

   Punkt 7

8. Hvis: alla(in_scope = true, punkt = 8)

   Paragraph 8 applies

   their version;

   Punkt 8

9. Hvis: alla(in_scope = true, punkt = 9)

   Paragraph 9 applies

   (d)

   Punkt 9

10. Hvis: alla(in_scope = true, punkt = 10)

    Paragraph 10 applies

    their validity period;

    Punkt 10

11. Hvis: alla(in_scope = true, punkt = 11)

    Paragraph 11 applies

    (e)

    Punkt 11

12. Hvis: alla(in_scope = true, punkt = 12)

    Paragraph 12 applies

    a normative part;

    Punkt 12

13. Hvis: alla(in_scope = true, punkt = 13)

    Paragraph 13 applies

    (f)

    Punkt 13

14. Hvis: alla(in_scope = true, punkt = 14)

    Paragraph 14 applies

    an explanatory part, including any relevant implementation guidelines.

    Punkt 14

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. By 26 March 2027, the Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements laid down in Annex II, including a common template and a time limit for implementing those common specifications. Where relevant, those common specifications shall take into account the specificities of medical devices and high-risk AI systems referred to in Article 27(1) and (2), respectively, including the state-of-the-art standards for health informatics and the European electronic health record exchange format. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. 22. The common specifications referred to in paragraph 1 shall include the following information and elements:
3. 3(a)
4. 4their scope;
5. 5(b)
6. 6their applicability to different categories of EHR systems or functions included in them;
7. 7(c)
8. 8their version;
9. 9(d)
10. 10their validity period;
11. 11(e)
12. 12a normative part;
13. 13(f)
14. 14an explanatory part, including any relevant implementation guidelines.

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

Sitering: 32025R0327 art. 36, Common specifications. NovaCopilot, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-36 (hämtad 2026-08-31, bevis sha256:ece4ca0c44c0f461, bygge legal-2026-11-02).