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
Recital 40
(40) Manufacturers should affix in the accompanying documents of the EHR system, and where applicable on its packaging, a CE marking of conformity indicating that the EHR system is in conformity with this Regulation and, in respect of aspects not covered by this Regulation, with other applicable Union law which also requires the affixing of such marking. Member States should build upon existing mechanisms to ensure the correct application of the provisions on the CE marking of conformity under relevant Union law and should take appropriate action in the event of improper use of that marking.