Agent · helsodata-2025-327-104
EHDS artikel 104: Amendment to Regulation (EU) 2024/2847
Structural tree: the article's own paragraphs, verbatim.
CELEX 32025R0327 · 2026-08-31 · Weight 62 · minimal-risk
OpenOpen reading. No metering is planned for this class.
- What this page is
- Agent, EHDS artikel 104
- Checked against the official source
- 2026-08-31Current
- Responsible publisher
- ExploreWorld Legal, editorial deskLiability position
Short answer
What does EHDS Article 104 require, and what outcome does the rule tree give?
EHDS Article 104 is tested here by a deterministic rule tree of 10 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 104Checked against the publisher 2026-08-31Official text
- Paragraph 1 applies. Regulation (EU) 2024/2847 is amended as follows:
- Paragraph 2 applies. (1)
- Paragraph 3 applies. in Article 13, paragraph 4 is replaced by the following:
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 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10)
Rule tree
If: alla(in_scope = true, punkt = 1)
Paragraph 1 applies
Regulation (EU) 2024/2847 is amended as follows:
Paragraph 1
If: alla(in_scope = true, punkt = 2)
Paragraph 2 applies
(1)
Paragraph 2
If: alla(in_scope = true, punkt = 3)
Paragraph 3 applies
in Article 13, paragraph 4 is replaced by the following:
Paragraph 3
If: 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…
Paragraph 4
If: alla(in_scope = true, punkt = 5)
Paragraph 5 applies
(2)
Paragraph 5
If: alla(in_scope = true, punkt = 6)
Paragraph 6 applies
in Article 31, paragraph 3 is replaced by the following:
Paragraph 6
If: 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.’
Paragraph 7
If: alla(in_scope = true, punkt = 8)
Paragraph 8 applies
(3)
Paragraph 8
If: alla(in_scope = true, punkt = 9)
Paragraph 9 applies
in Article 32, the following paragraph is inserted:
Paragraph 9
If: 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.
Paragraph 10
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
- 1Regulation (EU) 2024/2847 is amended as follows:
- 2(1)
- 3in Article 13, paragraph 4 is replaced by the following:
- 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(2)
- 6in Article 31, paragraph 3 is replaced by the following:
- 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(3)
- 9in Article 32, the following paragraph is inserted:
- 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.
Lineage
Interface
Hashes
Artefacts
No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.
Citation: 32025R0327 art. 104, Amendment to Regulation (EU) 2024/2847. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-104 (hämtad 2026-08-31, bevis sha256:ddc98cd002a843c6, bygge legal-2026-08-25).