+Article 39 1

Article 39 1

1.   The EU declaration of conformity referred to in Article 30(1), point (e), shall state that the manufacturer of an EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.

1. Pregled

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1.1 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi

3. Povezani standardi

Standardi