CE marking of conformity
Summary
CE marking must be visibly, legibly, and indelibly affixed before an EHR system is placed on the market, subject to the general CE-marking principles in Regulation (EC) No 765/2008.
ehr systemsconformityce marking
Read the full official text: https://eur-lex.europa.eu/eli/reg/2025/327/oj
← Article 36
Common specifications
Article 44 →
Handling of risks posed by EHR systems and of serious incidents
Track EHDS article 41 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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