European Health Data Space Regulation
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Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
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:
(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.
Related Recitals