+Članak 34.
---+Article 34 (a)
---+Article 34 (b)
---+Article 34 (c)

Članak 34.

Slučajevi u kojima se obveze proizvođača sustava elektroničkih zdravstvenih zapisa primjenjuju na druge subjekte ili pojedince

Uvoznik, distributer ili korisnik smatra se proizvođačem za potrebe ove Uredbe i podliježe obvezama utvrđenim u članku 30. ako:

(a)

stavi na raspolaganje na tržištu sustav elektroničkih zdravstvenih zapisa pod vlastitim imenom ili žigom;

(b)

izmijeni sustav elektroničkih zdravstvenih zapisa koji je već stavljen na tržište na način koji bi mogao utjecati na sukladnost s primjenjivim zahtjevima; ili

(c)

izmijene sustav elektroničkih zdravstvenih zapisa na način kojim se mijenja namjena koju je proizvođač naveo.

1. Pregled

Naslov	Regulativa
Article 34 (a)	make an EHR system available on the market under their own name or trademark;
Article 34 (b)	modify an EHR system already placed on the market in such a way that conformity with the applicable requirements might be affected; or
Article 34 (c)	modify an EHR system in such a way that it leads to changes in the intended purpose declared by the manufacturer.

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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