Agent · helsodata-2025-327-31

EHDS artikel 31: Authorised representatives

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. Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.

   Paragraph 1

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

   Paragraph 2 applies

   2. An authorised representative shall perform the tasks specified in the mandate agreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:

   Paragraph 2

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

   Paragraph 3 applies

   (a)

   Paragraph 3

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

   Paragraph 4 applies

   keep the EU declaration of conformity and the technical documentation referred to in Article 37 at the disposal of market surveillance authorities for the period referred to in Article 30(3);

   Paragraph 4

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

   Paragraph 5 applies

   (b)

   Paragraph 5

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

   Paragraph 6 applies

   further to a reasoned request from a market surveillance authority, provide authorities of the Member State concerned with a copy of the mandate and all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36;

   Paragraph 6

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

   Paragraph 7 applies

   (c)

   Paragraph 7

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

   Paragraph 8 applies

   inform without undue delay the manufacturer if the authorised representative has reason to believe that an EHR system is no longer in conformity with the essential requirements laid down in Annex II;

   Paragraph 8

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

   Paragraph 9 applies

   (d)

   Paragraph 9

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

    Paragraph 10 applies

    inform without undue delay the manufacturer about any complaint received from consumers or professional users;

    Paragraph 10

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

    Paragraph 11 applies

    (e)

    Paragraph 11

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

    Paragraph 12 applies

    cooperate with the market surveillance authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate;

    Paragraph 12

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

    Paragraph 13 applies

    (f)

    Paragraph 13

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

    Paragraph 14 applies

    terminate the mandate if the manufacturer does not comply with its obligations under this Regulation;

    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. Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.
2. 22. An authorised representative shall perform the tasks specified in the mandate agreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:
3. 3(a)
4. 4keep the EU declaration of conformity and the technical documentation referred to in Article 37 at the disposal of market surveillance authorities for the period referred to in Article 30(3);
5. 5(b)
6. 6further to a reasoned request from a market surveillance authority, provide authorities of the Member State concerned with a copy of the mandate and all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36;
7. 7(c)
8. 8inform without undue delay the manufacturer if the authorised representative has reason to believe that an EHR system is no longer in conformity with the essential requirements laid down in Annex II;
9. 9(d)
10. 10inform without undue delay the manufacturer about any complaint received from consumers or professional users;
11. 11(e)
12. 12cooperate with the market surveillance authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate;
13. 13(f)
14. 14terminate the mandate if the manufacturer does not comply with its obligations under this Regulation;

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

Citation: 32025R0327 art. 31, Authorised representatives. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-31 (hämtad 2026-08-31, bevis sha256:90da5af1be7c2247, bygge legal-2026-08-25).