+Article 30 5

Article 30 5

5.   Manufacturers of EHR systems shall, upon a reasoned request from a market surveillance authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements laid down in Annex II and the common specifications referred to in Article 36, in a language which can be easily understood by that market surveillance authority. The manufacturers of EHR systems shall cooperate with the market surveillance authority, at its request, on any measures taken to eliminate the risks posed by an EHR system which they have placed on the market or put into service.

1. Pregled

,
Naslov Regulativa

1.1 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi
Izvor Zahtjev

3. Povezani standardi

Standardi
Izvor Zahtjev
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