PMS and PMCF for EU MDR Compliance
PMS and PMCF are key requirements under EU MDR for ensuring ongoing safety and performance of medical devices. While both are related, PMS and PMCF serve different purposes in post-market activities.
PMS (Post-Market Surveillance):
- Defines system, objectives, and data collection methods
- Covers complaints, incidents, feedback, and trend analysis
- Includes risk management, CAPA, and communication
- Generates PMS Reports with conclusions and actions
PMCF (Post-Market Clinical Follow-Up):
- Focuses on clinical data collection after market launch
- Includes PMCF plan, objectives, and clinical activities
- Evaluates safety, performance, and real-world data
- Updates CER, risk files, and labeling if required
Key Difference:
- PMS: Broad monitoring of device performance
- PMCF: Clinical evaluation and evidence generation
PMS and PMCF ensure continuous compliance, safety, and performance of medical devices under EU MDR.