Post-Market Clinical Follow-up (PMCF) is a vital component of the EU MDR 2017/745. It ensures that once a medical device is CE-marked and available on the market, its long-term safety and performance continue to be monitored. The PMCF process culminates in the PMCF Report, which documents the findings and outcomes of ongoing clinical data collection.
What is PMCF?
PMCF is a continuous and proactive process of collecting and evaluating clinical data from the real-world use of a CE-marked device. The goal is to:
- Confirm the device’s long-term safety and performance,
- Identify emerging risks or new concerns,
- Ensure the clinical evaluation remains up to date.
When is PMCF needed?
PMCF activities are particularly important in the following situations:
- When there are unanswered questions about long-term safety, performance, or effectiveness.
- For novel technologies or new intended uses.
- For higher-risk devices and complex use scenarios.
- When approval was based on equivalent device data, requiring confirmation in real-world settings.
In some cases, PMCF may not be necessary—for example, when sufficient long-term safety and performance data already exists or when other post-market surveillance (PMS) activities adequately address uncertainties.
PMCF Activities
- General PMCF Activities (for low-risk devices)
➡️ These activities mainly produce subjective data, which cannot be used alone to scientifically confirm safety and performance.
- Specific PMCF Activities (for high-risk devices)
➡️ These produce objective, scientifically sound data that can demonstrate safety and performance and address regulatory uncertainties.
PMCF Report: Purpose and Content
The PMCF Report consolidates and analyzes the data collected through PMCF activities. Its purpose is to:
- Provide evidence of continued compliance with the General Safety and Performance Requirements (GSPR).
- Document how residual risks and uncertainties are being addressed.
- Support updates to the Clinical Evaluation Report (CER) and the overall technical documentation.
A PMCF Report typically includes:
- A description of PMCF activities performed.
- Data collected (feedback, literature, surveys, clinical studies).
- Analysis of results and identification of new risks.
- Conclusions on the device’s ongoing safety and performance.
- Recommendations for updates to the risk management file, IFU, or CER.
Why does PMCF matter?
Under EU MDR, manufacturers are expected to demonstrate ongoing compliance throughout the device lifecycle. PMCF Reports are not just regulatory paperwork—they are tools to:
- Build trust with regulators, healthcare professionals, and patients.
- Ensure early detection of risks.
- Strengthen the clinical evidence base for a device.
In summary, the PMCF Report serves as the bridge between real-world use and regulatory compliance, ensuring that medical devices remain safe, effective, and reliable throughout their market life.
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