+Article 30 4

Article 30 4

4.   A manufacturer of EHR systems established outside the Union shall ensure that its authorised representative has the necessary documentation readily available in order to fulfil the tasks referred to in Article 31(2).

1. Pregled

,

1.1 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi

3. Povezani standardi

Standardi