Module 16 2022

05/09/2022

Importance of Post–Market Surveillance

• Enables the detection of problems • Confirms adequacy of the instructions for use • Verification of the risk analysis • Allows a review of the long term safety and performance • Signals the off label use of the device • Allows an assessment of the device against competitors • Review of State of the Art • Identification of incidents and Field safety corrective actions

The Organisation for Professionals in Regulatory Affairs

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Notified Body Assessment [1/4]

• Does the manufacturer have a QMS that has been implemented correctly, is robust and that complies with Article 10, including • Risk management system

• Clinical evaluation including a PMCF • Post-market surveillance system • Vigilance processes

• Post-market surveillance processes are in place and being operated • Vigilance procedures are in line with requirements (Article 87)

The Organisation for Professionals in Regulatory Affairs

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