CHAPTER III · EHR SYSTEMS AND WELLNESS APPLICATIONS
Article 34Cases 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.