+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. Resumen

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Título Regulación

1.1 Referencias

1.2 Requisitos identificados

1.3 Estándares relacionados

2. Requisitos identificados

Requisitos
Fuente Requisito

3. Estándares relacionados

Estándares
Fuente Requisito