Placing on the market and putting into service
Summary
EHR systems (including SaaS-delivered EHR systems and those manufactured/used within health institutions) may only be placed on the market or put into service if they comply with Chapter III.
ehr systemsconformity
Read the full official text: https://eur-lex.europa.eu/eli/reg/2025/327/oj
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Harmonised software components of EHR systems
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Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
Track EHDS article 26 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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