+Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
---+Article 34 (a)
---+Article 34 (b)
---+Article 34 (c)

Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals

An importer, distributor or user shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 30 where they:

1. Panoramica

,
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 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti

3. Standard correlati

Standard