PMS AND POST-MARKET CLINICAL FOLLOW-UP (PMCF)

Strategy and management of post-market surveillance according to MDR

Regulation (EU) 2017/745 requires manufacturers to maintain an organized and proactive post-market surveillance (PMS) system aimed at confirming over time:

• safety
• performance
• clinical benefit
• benefit/risk ratio

FTR Advisor supports manufacturers in designing, implementing, and optimizing the PMS and Post-Market Clinical Follow-up (PMCF) system, consistent with MDR and MDCG guidelines.

Request a preliminary assessment of your PMS system

Our methodological approach

1. PMS and PMCF Plan Design.

We support in the definition of:

• Study of the medical device and available data
• Design of the most appropriate data collection system
• Selection of data sources (proactive and reactive)
• Definition of Performance and Safety Indicators
• Definition of trend analysis criteria
• Drafting the PMCF Plan

We ensure consistency with device class, risk, and clinical context.

2. System implementation.

• PMCF activities (surveys, observational studies, registries, structured data collection)
• Monitoring
• Analysis of post-market data collected
• Support in the analysis and management of relevant deviations

We ensure traceability and document consistency.

3. Reporting and updating of documentation

• Drafting PSUR or PMS Report (for class I medical devices)
• CER update
• Risk Management Update.

The PMS system must dynamically feed the clinical assessment and risk management document.

When to intervene?

When:

• The transition from MDD to MDR is underway.
• The Notified Body requests strengthening of the PMCF
• The ERC highlights evidence gaps
• Emerging trends or signals are found
• PSUR needs to be drafted or updated