Entering the EU Medical Device Market is just the beginning. Maintaining compliance throughout your product’s lifecycle is where the real challenge begins and that’s where Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) come in.
đź› Post-Market Surveillance (PMS)
PMS is the overall process for gathering, analyzing and evaluating data on the performance and safety of a medical device after it has been placed on the market. This includes
✔️ Incident and complaint reporting
✔️ User feedback and trend analysis
✔️ Vigilance and corrective/preventive actions (CAPA)
Applicable to all device classes, PMS ensures your device remains compliant and safe over time.
🔬 Post-Market Clinical Follow-up (PMCF)
PMCF is a subprocess within the PMS plan and focuses specifically on the collection of clinical data to confirm safety and performance in real-world use. It helps:
✔️ Validate benefit-risk ratio
✔️ Identify unknown side effects or risks
✔️ Detect misuse or off-label use
PMCF activities often include clinical studies, patient registries, or observational data and are required unless clearly justified otherwise.
đź“Ś Key Takeaways:
• PMS = all post-market data sources
• PMCF = only clinical data
• Both must be initiated before CE marking and maintained throughout the product lifecycle
• PMCF is mandatory for Class III and implantable devices and often recommended for others
Make sure your PMS and PMCF plans are well-structured, documented and integrated into your QMS and risk management processes.
Get more information: Post-Market Surveillance & Monitoring
or contact us to ensure compliance with EU MDR
- WQS Management Consultants Inc.
