New EU Regulation for EHR-Compatible Medical Software and Devices
In 2024, Regulation (EU) 2025/327 was adopted, which governs the sharing of electronic health data between Member States and the interoperability of EHR systems.
Who is affected?
Devices and software used for diagnostics, therapy, or based on AI that:
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are connected to an EHR system, or
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claim to be compatible with one.
Requirements:
Manufacturers must demonstrate:
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the technical details of interoperability (according to Annex II),
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compatibility with European EHR components,
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the safety and performance of the software.
All such products must be registered in a new EU database.
Entry into force:
From March 26, 2027, only fully compliant products may be placed on the market.
