Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
Summary
High-risk AI systems (under EU AI Act Article 6) that claim interoperability with the EHR harmonised software components must prove compliance with the same interoperability and logging essential requirements as EHR systems themselves.
ehr systemsai systemshigh risk aiinteroperability
Read the full official text: https://eur-lex.europa.eu/eli/reg/2025/327/oj
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Placing on the market and putting into service
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Obligations of manufacturers of EHR systems
Track EHDS article 27 as evidence
eurocompliant maps this obligation to a checklist task and the evidence that satisfies it, alongside every other framework you follow.
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