Agent · helsodata-2025-327-104

EHDS artikel 104: Amendment to Regulation (EU) 2024/2847

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Strukturelt tre: artikkelens egne punkter, ordrett.

Søkes også som: forordning (EU) 2025/327 artikkel 104

CELEX 32025R0327 · 2026-08-31 · Vekt 62 · 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)

Regeltre

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

   Paragraph 1 amends another act, no direct obligation for businesses

   Regulation (EU) 2024/2847 is amended as follows:

   Punkt 1

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

   Paragraph 2 applies

   (1)

   Punkt 2

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

   Paragraph 3 amends another act, no direct obligation for businesses

   in Article 13, paragraph 4 is replaced by the following:

   Punkt 3

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

   Paragraph 4 applies

   ‘4. When placing a product with digital elements on the market, the manufacturer shall include the cybersecurity risk assessment referred to in paragraph 3 of this Article in the technical documentation required pursuant to Article 31 and Annex VII. For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts, the cybersecurity risk assessment ma…

   Punkt 4

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

   Paragraph 5 applies

   (2)

   Punkt 5

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

   Paragraph 6 amends another act, no direct obligation for businesses

   in Article 31, paragraph 3 is replaced by the following:

   Punkt 6

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

   Paragraph 7 applies

   ‘3. For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts which provide for technical documentation, a single set of technical documentation shall be drawn up containing the information referred to in Annex VII and the information required by those Union legal acts.’

   Punkt 7

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

   Paragraph 8 applies

   (3)

   Punkt 8

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

   Paragraph 9 amends another act, no direct obligation for businesses

   in Article 32, the following paragraph is inserted:

   Punkt 9

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

    Paragraph 10 applies

    ‘5a. Manufacturers of products with digital elements that are classified as EHR systems under Regulation (EU) 2025/327 of the European Parliament and of the Council (*1) shall demonstrate conformity with the essential requirements set out in Annex I to this Regulation using the relevant conformity assessment procedure provided for in Chapter III of Regulation (EU) 2025/327.

    Punkt 10

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. 1Regulation (EU) 2024/2847 is amended as follows:
2. 2(1)
3. 3in Article 13, paragraph 4 is replaced by the following:
4. 4‘4. When placing a product with digital elements on the market, the manufacturer shall include the cybersecurity risk assessment referred to in paragraph 3 of this Article in the technical documentation required pursuant to Article 31 and Annex VII. For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts, the cybersecurity risk assessment may be part of the risk assessment required by those Union legal acts. Where certain essential cybersecurity requirements are not applicable to the product with digital elements, the manufacturer shall include a clear justification to that effect in that technical documentation.’
5. 5(2)
6. 6in Article 31, paragraph 3 is replaced by the following:
7. 7‘3. For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts which provide for technical documentation, a single set of technical documentation shall be drawn up containing the information referred to in Annex VII and the information required by those Union legal acts.’
8. 8(3)
9. 9in Article 32, the following paragraph is inserted:
10. 10‘5a. Manufacturers of products with digital elements that are classified as EHR systems under Regulation (EU) 2025/327 of the European Parliament and of the Council (*1) shall demonstrate conformity with the essential requirements set out in Annex I to this Regulation using the relevant conformity assessment procedure provided for in Chapter III of Regulation (EU) 2025/327.

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

Sitering: 32025R0327 art. 104, Amendment to Regulation (EU) 2024/2847. NovaCopilot, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-104 (hämtad 2026-08-31, bevis sha256:6c610420b2a7cba5, bygge legal-2026-11-03).