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