Essentials of European Medical Device Regulatory Affairs - October 2019

Post Market Surveillance PMS The PMS System • Requirement for all manufacturers

• Appropriate for the device and risk class • Active, systematic continuous process: – Gathering quality, performance and safety data – Recording – Analysing – Reaching conclusions – Determining, implementing, monitoring CAPAs – Feedback into other processes • PMS plan and reports

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Post Market Surveillance PMS

Surveillance • Complaints Management • Customer satisfaction surveys • Literature review • User group feedback sessions • PMCF (Post market clinical follow up)

Vigilance

• Serious incidents • Field Safety Corrective  actions (FSCA)

Proactive

Reactive

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