+Article 31 1

Article 31 1

1.   Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.

1. Ħarsa ġenerali

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Titlu Regolamentazzjoni

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors Rekwiżit

3. Standards relatati

Standards
Sors Rekwiżit