Agent · helsodata-2025-327-33

EHDS artikel 33: Obligations of distributors

Strukturelt tre: artikkelens egne punkter, ordrett.

CELEX 32025R0327 · 2026-08-31 · Vekt 70 · minimal-risk

OpenOpen reading. No metering is planned for this class.

EHDSOffisiell kilde

Inndata

• in_scopeThe article applies to the situationboolean
• punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12)

Regeltre

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

   Paragraph 1 applies

   1. Before making an EHR system available on the market, distributors shall verify that:

   Punkt 1

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

   Paragraph 2 applies

   (a)

   Punkt 2

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

   Paragraph 3 applies

   the manufacturer has drawn up the EU declaration of conformity;

   Punkt 3

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

   Paragraph 4 applies

   (b)

   Punkt 4

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

   Paragraph 5 applies

   the EHR system bears the CE marking of conformity;

   Punkt 5

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

   Paragraph 6 applies

   (c)

   Punkt 6

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

   Paragraph 7 applies

   the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use in accessible formats;

   Punkt 7

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

   Paragraph 8 applies

   (d)

   Punkt 8

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

   Paragraph 9 applies

   where applicable, the importer has complied with the requirements set out in Article 32(3).

   Punkt 9

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

    Paragraph 10 applies

    2. Distributors shall ensure that, while an EHR system is under their responsibility, the EHR system is not altered in such a way that its conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 is jeopardised.

    Punkt 10

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

    Paragraph 11 applies

    3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42, it shall not make that EHR system available on the market until it has been brought into conformity. The distributor shall inform without undue delay the manufacturer or the importer, as well as the market surv…

    Punkt 11

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

    Paragraph 12 applies

    4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring an EHR system int…

    Punkt 12

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. 11. Before making an EHR system available on the market, distributors shall verify that:
2. 2(a)
3. 3the manufacturer has drawn up the EU declaration of conformity;
4. 4(b)
5. 5the EHR system bears the CE marking of conformity;
6. 6(c)
7. 7the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use in accessible formats;
8. 8(d)
9. 9where applicable, the importer has complied with the requirements set out in Article 32(3).
10. 102. Distributors shall ensure that, while an EHR system is under their responsibility, the EHR system is not altered in such a way that its conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 is jeopardised.
11. 113. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42, it shall not make that EHR system available on the market until it has been brought into conformity. The distributor shall inform without undue delay the manufacturer or the importer, as well as the market surveillance authorities of the Member States where the EHR system has been or is to be made available on the market, to that effect. Where a distributor considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons, it shall inform the market surveillance authorities of the Member State in which the distributor is established, as well as the manufacturer and the importer.
12. 124. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring an EHR system into conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 or to recall or withdraw it.

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

Sitering: 32025R0327 art. 33, Obligations of distributors. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-33 (hämtad 2026-08-31, bevis sha256:f5be4d2cae52513f, bygge legal-2026-08-25).