Obligations of manufacturers of EHR systems
Summary
EHR system manufacturers must ensure conformity with Annex II essential requirements, draw up technical documentation, issue an EU declaration of conformity, affix CE marking, register in the EU database, and handle non-conformity/corrective action.
ehr systemsmanufacturer obligationsconformity
Read the full official text: https://eur-lex.europa.eu/eli/reg/2025/327/oj
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Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
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Common specifications
Track EHDS article 30 as evidence
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