Keep risk, clinical and post-market evidence current and assess changes in intended purpose, software, sterilisation, suppliers and device families. Follow the body's applicable notification and reassessment conditions where involved. Plan renewal using the issued certificate and selected procedure; renewal does not automatically approve changed devices or replace continuing vigilance duties.
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.
Review effects on intended use, clinical decisions, performance and risks. An interface correction differs from adding a diagnostic function. Update verification, risk and clinical evidence where needed and make required notifications. A minor version-number change does not establish a minor regulatory effect.
The exact records for MDR Renewal and Surveillance depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.
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