Article 34

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

In short: An importer, distributor or user shall be considered a manufacturer if they either modify an EHR system already on the market, or if they sell the EHR using their own product name.

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:

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

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