MDR assessment depends on the selected conformity route and device class. Where a notified body is involved, prepare the relevant quality-system and technical documentation, clinical evidence, validation and critical supplier records. Demonstrate change control and corrective-action closure. A general ISO audit does not automatically complete device conformity assessment.
Assess effects of the new site, method or process on sterility and device characteristics. Review validation, packaging, shelf life and biological safety as needed. Follow the relevant notified body's change and notification rules. The same service name does not establish coverage by earlier evidence.
Assess the event, potential harm, recurrence and affected devices promptly. Consider MDR vigilance, reporting and field safety duties under their specific conditions and deadlines. Complaints do not all lead to identical actions, but required reporting should not wait for a definitive cause. Keep decisions and follow-up traceable.
The exact records for MDR Audit Process depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.
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