+Article 44 9

Article 44 9

9.   Where its tasks are not performed by the digital health authority, the market surveillance authority shall cooperate with the digital health authority. The market surveillance authority shall inform the digital health authority of any serious incidents, of EHR systems presenting a risk, including risks related to interoperability, security and patient safety, of any corrective action and of any recall or withdrawal of such EHR systems.

1. Pregled

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Naslov Regulativa

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve
Vir Zahteva

3. Povezani standardi

Standardi
Vir Zahteva