Part 4A Post-market surveillance requirementsF1

England, Wales and Scotland

1. 44ZCInterpretation of Part 4A
2. 44ZDScope of Part 4A
3. 44ZEPost-market surveillance system
4. 44ZFPost-market surveillance plan
5. 44ZGPreventive and corrective actions
6. 44ZHInitial reporting of serious incidents
7. 44ZIInvestigation and final reporting of serious incidents
8. 44ZJField safety corrective actions and field safety notices
9. 44ZKField safety corrective actions outside Great Britain
10. 44ZLPost-market surveillance report
11. 44ZMPeriodic safety update report
12. 44ZNTrend reporting
13. 44ZOReports received by the Secretary of State
14. 44ZPAnalysis of information received under Part 4A
15. 44ZQRetention of post-market surveillance documentation
16. 44ZRRequests for post-market surveillance documentation