Agent · helsodata-2025-327-30

EHDS artikel 30: Obligations of manufacturers of EHR 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.

EHDSOfficial source

Inputs

• 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)

Rule tree

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

   Paragraph 1 applies

   1. Manufacturers of EHR systems shall:

   Paragraph 1

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

   Paragraph 2 applies

   (a)

   Paragraph 2

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

   Paragraph 3 applies

   ensure that the harmonised software components of their EHR systems and the EHR systems themselves, to the extent that this Chapter establishes requirements for them, are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 36;

   Paragraph 3

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

   Paragraph 4 applies

   (b)

   Paragraph 4

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

   Paragraph 5 applies

   ensure that the harmonised software components of their EHR systems are not adversely affected by other software components of the same EHR system;

   Paragraph 5

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

   Paragraph 6 applies

   (c)

   Paragraph 6

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

   Paragraph 7 applies

   draw up the technical documentation of their EHR systems in accordance with Article 37 before placing those EHR systems on the market, and subsequently keep it up to date;

   Paragraph 7

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

   Paragraph 8 applies

   (d)

   Paragraph 8

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

   Paragraph 9 applies

   ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 38 and clear and complete instructions for use;

   Paragraph 9

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

    Paragraph 10 applies

    (e)

    Paragraph 10

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

    Paragraph 11 applies

    draw up the EU declaration of conformity in accordance with Article 39;

    Paragraph 11

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

    Paragraph 12 applies

    (f)

    Paragraph 12

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

    Paragraph 13 applies

    affix the CE marking of conformity in accordance with Article 41;

    Paragraph 13

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

    Paragraph 14 applies

    (g)

    Paragraph 14

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. Manufacturers of EHR systems shall:
2. 2(a)
3. 3ensure that the harmonised software components of their EHR systems and the EHR systems themselves, to the extent that this Chapter establishes requirements for them, are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 36;
4. 4(b)
5. 5ensure that the harmonised software components of their EHR systems are not adversely affected by other software components of the same EHR system;
6. 6(c)
7. 7draw up the technical documentation of their EHR systems in accordance with Article 37 before placing those EHR systems on the market, and subsequently keep it up to date;
8. 8(d)
9. 9ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 38 and clear and complete instructions for use;
10. 10(e)
11. 11draw up the EU declaration of conformity in accordance with Article 39;
12. 12(f)
13. 13affix the CE marking of conformity in accordance with Article 41;
14. 14(g)

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

Citation: 32025R0327 art. 30, Obligations of manufacturers of EHR systems. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-30 (hämtad 2026-08-31, bevis sha256:29d20540c27ceae6, bygge legal-2026-08-25).