Post-Market Performance Follow-up (PMPF)

Bringing an in vitro diagnostic (IVD) device to market is only the beginning. Under the In Vitro Diagnostic Regulation (IVDR), your responsibilities don’t end after CE marking.

To ensure your device continues to meet safety, scientific validity, and performance standards, ongoing Post-Market Performance Follow-up (PMPF) is required.

At QbD IVD | Qarad, we help you turn PMPF into a practical, structured process—supporting your regulatory compliance and safeguarding patient outcomes.

Pre-market vs post-market

Pre-market

Before placing a device on the market, manufacturers must establish:

Scientific validity
Analytical performance
Clinical performance This forms the basis of the Performance Evaluation Report (PER) and ensures compliance at launch.

Post-market

Once your device is on the market, PMPF activities take over. PMPF confirms the continued validity of your device’s performance, scientific validity, and benefit-risk ratio—under real-world conditions. It allows you to:

Detect emerging risks
Update the state of the art
Monitor similar devices
Stay compliant with IVDR

What is Post-Market Performance Follow-up (PMPF)?

PMPF, part of the broader PMS (Post-Market Surveillance) process, is the ongoing proactive collection and evaluation of performance data from real-world use of your IVD device.

While PMS gathers a wide range of safety and performance data, PMPF specifically focuses on confirming scientific validity and clinical performance under routine diagnostic conditions. It is an iterative process, designed to ensure the continued acceptability of the benefit-risk ratio and to detect any emerging risks.

Common PMPF activities include:

Type of method	Examples
Scientific validity	Literature search (protocol & report)
Clinical performance	Literature search (protocol & report), evaluation of registries
Vigilance data analysis	Database screening, search protocols & impact analysis reports
State of the Art review	Monitoring guidelines, scientific literature, similar products
Manufacturer’s data	Customer feedback, CAPAs, manufacturing info
Optional methods	EQA schemes, patient/disease registries, genetic databanks, PMPF studies

Discover how we can help you

Common PMPF challenges we help you overcome

We provide tailored solutions to help you stay ahead—without draining your internal resources. IVD manufacturers often struggle with:

Defining a clear PMPF strategy and plan

Systematic and objective literature screening

Confirming clinical performance and scientific validity

Keeping up with the state of the art and regulatory changes

Analyzing vigilance databases and manufacturer’s internal data

Managing resource peaks for recurring PMS activities

Ensuring timely and audit-ready documentation

Why QbD Group?

We support IVD manufacturers with hands-on PMPF expertise, offering a full-service solution tailored to your needs. Our team helps with:

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

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.

✔️ IVDR-compliant
✔️ Customized approach
✔️ Proven track record with global IVD leaders

Get in touch

Interested in our PMPF support? Don’t hesitate to contact us and share the details of your devices. We’ll be happy to set up a call to discuss your needs, scope, and timeline.

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Resources

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

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