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:

(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.