Handling of risks posed by EHR systems and of serious incidents
Summary
Manufacturers must report any serious incident involving an EHR system to market surveillance authorities no later than 3 days after becoming aware of it (once a causal link is established), and cooperate on corrective action.
ehr systemsincident reportingmarket surveillance
Read the full official text: https://eur-lex.europa.eu/eli/reg/2025/327/oj
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Essential requirements for identification and authentication of health professionals
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