EHDS, Article 32, DE

1. Importers shall place on the Union market only EHR systems which are in conformity with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36.

2. Before making an EHR system available on the market, importers shall ensure that:

(a)

the manufacturer has drawn up the technical documentation referred to in Article 37 and the EU declaration of conformity;

(b)

the manufacturer is identified and an authorised representative has been appointed in accordance with Article 31;

(c)

the EHR system bears the CE marking of conformity referred to in Article 41 after the conformity assessment procedure has been completed;

(d)

the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use, including for its maintenance, in accessible formats.

3. Importers shall indicate their name, registered trade name or registered trade mark, the postal address, website, email address or other digital contact details through which they can be contacted in a document accompanying the EHR system. The contact details shall indicate a single point at which the manufacturer can be contacted and shall be in a language which can be easily understood by users and market surveillance authorities. Importers shall ensure that any additional label does not conceal or obscure any of the information provided by the manufacturer that appears on any original label which is provided for the EHR system.

4. Importers 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.

5. Where an importer considers or has reason to believe that an EHR system is not or is no longer 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, or, if that EHR system was already placed on the market, shall recall or withdraw it, until the EHR system has been brought into conformity. In the event of such recall or withdrawal, the importer shall inform without undue delay the manufacturer of such EHR system, the users and the market surveillance authorities of the Member State in which it made the EHR system available on the market of such recall or withdrawal, giving details, in particular, of the non-conformity and of any corrective measures taken.

Where an importer considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons, it shall without undue delay inform the market surveillance authorities of the Member State in which it is established, as well as the manufacturer and, where applicable, the authorised representative.

Official source

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Source: NovaCopilot