+Article 33 1

Article 33 1

1.   Before making an EHR system available on the market, distributors shall verify that:

(a)

the manufacturer has drawn up the EU declaration of conformity;

(b)

the EHR system bears the CE marking of conformity;

(c)

the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use in accessible formats;

(d)

where applicable, the importer has complied with the requirements set out in Article 32(3).

1. Overzicht

,

1.1 Referenties

1.2 Geïdentificeerde eisen

1.3 Gerelateerde standaarden

2. Geïdentificeerde eisen

Eisen

3. Gerelateerde standaarden

Standaarden