+Article 45 1

Article 45 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:

(a)

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;

(b)

the technical documentation is not available, not complete or not in accordance with Article 37;

(c)

the EU declaration of conformity has not been drawn up or has not been drawn up correctly in accordance with Article 39;

(d)

the CE marking of conformity has been affixed in breach of Article 41 or has not been affixed;

(e)

the registration obligations of Article 49 have not been fulfilled.

1. Pregled

,

1.1 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi

3. Povezani standardi

Standardi
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