With the adoption of Regulation (EU) 2025/327 the European Union has officially established the European Health Data Space (EHDS), introducing important innovations for manufacturers of Medical Devices and in vitro diagnostics.
Regulation (EU) 2025/327 amends Directive 2011/24/EU and Regulation (EU) 2024/2847 to create a common framework for the use and exchange of electronic health data in the European Union. The Regulation was published in the Official Journal of the European Union on March 5, 2025 and entered into force on March 25, 2025. The first obligations will apply from March 2027. The implementation of the regulation will take place in stages.
Medical Devices claiming interoperability with Electronic Health Record (EHR) systems will have to demonstrate compliance with security, interoperability and logging requirements. To clarify, EHR systems, or digital health record systems, consist of software, or a combination of hardware and software, that enable the processing of electronic health data. The regulation introduces specific obligations for economic actors involved in the supply of these systems, including manufacturers, importers and distributors.
In the event that the product falls under both the definition of EHR and medical device, it will have to comply with the requirements of both regulations, including the provisions on registration in EUDAMED.
Wellness applications that interact with EHRs will also be subject to a new labelling, which will have to indicate compliance with the common specifications under the regulation.
In addition to fostering innovation and research, the EHDS aims to improve patient access to electronic health data (primary use) and to facilitate their use for public interest purposes, such as clinical trials and the development of digital solutions (secondary use).
To support cross-border healthcare, the MyHealth@EU platform is planned, which will connect the digital contact points of individual Member States.
For further information, the European Commission has published an FAQ section on the European Health Data Area.
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SOURCE:
04/15/2025
