Post-Market Performance Follow-up (PMPF)
Proactive collection and evaluation of IVD data
At QbD IVD | Qarad, we help you turn PMPF into a practical, structured process—supporting your regulatory compliance and safeguarding patient outcomes.
What is Post-Market Performance Follow-up (PMPF)?
PMPF, part of the broader PMS process, is the ongoing proactive collection and evaluation of data from real-world use of your IVD device.
Under IVDR, responsibilities don't end after CE marking. PMPF confirms performance and the risk-benefit ratio under routine conditions. It is an iterative process detecting emerging risks and ensuring continued acceptability.
Pre-market vs post-market
Understanding the lifecycle obligations is key to compliance.
Pre-market
Establish scientific validity, analytical performance, and clinical performance for the Performance Evaluation Report (PER).
Post-market
Confirm continued validity of performance and benefit-risk ratio. Detect emerging risks and update state of the art.
Common PMPF challenges we help you overcome
We provide tailored solutions to help you stay ahead without draining resources. IVD manufacturers often struggle with:
Strategy
Defining a clear PMPF strategy and plan.
Screening
Systematic and objective literature screening.
Validation
Confirming clinical performance and scientific validity.
Updates
Keeping up with state of the art and regulatory changes.
Vigilance analysis
Analyzing vigilance databases and manufacturer's internal data.
Resource management
Managing resource peaks for recurring PMS activities.
Documentation
Ensuring timely and audit-ready documentation.
Common PMPF activities
| Type of method | Examples |
|---|---|
| Scientific validity | Literature search (protocol & report) |
| Clinical performance | Literature search, evaluation of registries |
| Vigilance data analysis | Database screening |
| State of the Art review | Monitoring guidelines, scientific literature |
| Optional methods | EQA schemes, registries, PMPF studies |
Why QbD Group
Your trusted partner
We support IVD manufacturers with hands-on PMPF expertise, offering a full-service solution tailored to your needs. Thanks to our medical writing expertise, regulatory know-how, and deep understanding of IVDs, we offer a time- and cost-effective solution to meet IVDR requirements with confidence.
Developing your PMPF strategy and plan.
Executing literature and database searches.
Analyzing internal and external data sources.
Preparing compliant PMPF documentation.
Updating your PER and Risk Management File.
✔️ IVDR-compliant | ✔️ Customized approach | ✔️ Proven track record with global IVD leaders
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