Module 16 2024

17/10/2024

The post-market surveillance plan

PMCF PLAN

PMS Procedure

Technical Documentation Procedure

Complaints Handling Procedure Vigilance /Reporting Procedure Risk Management Procedure

Clinical Evaluation Procedure

PMS PLAN

Device Traceability Procedure

CAPA Procedure

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The post-market surveillance plan

• The MDR PMS requirements of can be broken into the following general processes:

1. Post-market surveillance 2. Post-market data assessment

3. Risk management and benefit/risk 4. Complaint investigation and analysis 5. Trend analysis and reporting 6. Communications 7. General PMS, PMS planning and PSUR 8. Corrective and preventative action 9. Product traceability 10.Specific methods of PMCF 11.PMCF plan 12.Post-market surveillance reporting 13.Technical documentation maintenance

PMS PLAN

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