art_32__para_5

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.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.