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 42
(42) Certain software components of EHR systems could be considered medical devices under Medical Devices Regulation (MDR) or in vitro diagnostic medical devices under In Vitro Diagnostic Regulation (IVDR) of the European Parliament and of the Council . Software or modules of software which fall within the definition of a medical device, in vitro diagnostic medical devices or an artificial intelligence (AI) system considered to be high-risk (the ‘high-risk AI system’) should be certified in accordance with Medical Devices Regulation (MDR), (EU) 2017/746 and (EU) 2024/1689, as applicable. While such products are required to fulfil the requirements under the respective Regulation governing those products, Member States should take appropriate measures to ensure that the respective conformity assessment is carried out as a joint or coordinated procedure in order to limit the administrative burden on manufacturers and other economic operators. The essential requirements on interoperability of this Regulation should only apply to the extent that the manufacturer of a medical device, an in vitro diagnostic medical device, or a high-risk AI system, which is providing electronic health data to be processed as part of the EHR system, claims interoperability with such EHR system. In such case, the provisions on common specifications for EHR systems should be applicable to those medical devices, in vitro diagnostic medical devices and high-risk AI systems.