Reports Requiring Notification for Medical Devices

Reports Requiring Notification for Medical Devices

The production of medical devices must be carried out in accordance with the relevant standards and regulations for human health. All ready-to-use medical devices must be tested and evaluated at regular intervals to demonstrate suitability in accordance with MDR (Medical Device Regulation) requirements. Reports to be prepared to meet MDR (Medical Device Regulation) requirements are as follows:

1.Clinical Data Evaluation Report (CER)
2.Post-Market Clinical Surveillance Report (PMCF - Evaluation Report)
3.Post-Market Surveillance Report (PMSR - Market Surveillance Report)
4.Periodic Safety Update Report (PSUR -Periodic Safety Update Report)
5.Summary of Safety and Clinical Performance (SSCP - summary of safety and clinical performance)