art_45__para_1

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: 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; the technical documentation is not available, not complete or not in accordance with Article 37; the EU declaration of conformity has not been drawn up or has not been drawn up correctly in accordance with Article 39; the CE marking of conformity has been affixed in breach of Article 41 or has not been affixed; the registration obligations of Article 49 have not been fulfilled.

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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.