Agent · helsodata-2025-327-45

EHDS artikel 45: Handling of non-compliance

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. Where a market surveillance authority makes a finding of non-compliance, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to take, by a specific deadline, adequate corrective action to bring the EHR system into conformity. Such findings of non-compliance include, but are not limited to, the following:

   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

   the EHR system is not in conformity with essential requirements laid down in Annex II or with the common specifications referred to in 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

   the technical documentation is not available, not complete or not in accordance with Article 37;

   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

   the EU declaration of conformity has not been drawn up or has not been drawn up correctly in accordance with Article 39;

   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

   the CE marking of conformity has been affixed in breach of Article 41 or has not been affixed;

   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

    the registration obligations of Article 49 have not been fulfilled.

    Paragraph 11

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

    Paragraph 12 applies

    2. Where the manufacturer of the EHR system concerned, its authorised representative or any other relevant economic operator does not take adequate corrective action within a reasonable period, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EHR system from being made available on the market of their Member States, or to recall or withdraw the EHR system…

    Paragraph 12

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

    Paragraph 13 applies

    The market surveillance authorities shall inform the Commission and the other Member States’ market surveillance authorities, without delay, of those provisional measures. That information shall include all available details, in particular the data necessary for the identification of the non-compliant EHR system, the origin of that EHR system, the nature of the non-compliance alleged and the risk involved, the nature…

    Paragraph 13

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

    Paragraph 14 applies

    (a)

    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. Where a market surveillance authority makes a finding of non-compliance, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to take, by a specific deadline, adequate corrective action to bring the EHR system into conformity. Such findings of non-compliance include, but are not limited to, the following:
2. 2(a)
3. 3the EHR system is not in conformity with essential requirements laid down in Annex II or with the common specifications referred to in Article 36;
4. 4(b)
5. 5the technical documentation is not available, not complete or not in accordance with Article 37;
6. 6(c)
7. 7the EU declaration of conformity has not been drawn up or has not been drawn up correctly in accordance with Article 39;
8. 8(d)
9. 9the CE marking of conformity has been affixed in breach of Article 41 or has not been affixed;
10. 10(e)
11. 11the registration obligations of Article 49 have not been fulfilled.
12. 122. Where the manufacturer of the EHR system concerned, its authorised representative or any other relevant economic operator does not take adequate corrective action within a reasonable period, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EHR system from being made available on the market of their Member States, or to recall or withdraw the EHR system from that market.
13. 13The market surveillance authorities shall inform the Commission and the other Member States’ market surveillance authorities, without delay, of those provisional measures. That information shall include all available details, in particular the data necessary for the identification of the non-compliant EHR system, the origin of that EHR system, the nature of the non-compliance alleged and the risk involved, the nature and duration of the measures taken by the market surveillance authorities and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:
14. 14(a)

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

Citation: 32025R0327 art. 45, Handling of non-compliance. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-45 (hämtad 2026-08-31, bevis sha256:5bd9375bb5cce24b, bygge legal-2026-08-25).