Article 21, Cases in which obligations of manufacturers of an EHR system apply to importers and distributors, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
Cases in which obligations of manufacturers of an EHR system apply to importers and distributors.
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 17, where they made an EHR system available on the market under their own name or trademark or modify an EHR system already placed on the market in such a way that conformity with the applicable requirements may be affected.