---
title: "Post-Market Performance Follow-up (PMPF) — Clinical Solutions | QbD Group"
description: "At QbD IVD | Qarad, we help you turn PMPF into a practical, structured process—supporting your regulatory compliance and safeguarding patient outcomes."
url: https://qbdgroup.com/en/services/clinical-solutions/pmpf
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Post-Market Performance Follow-up (PMPF) — Clinical Solutions | QbD Group\", https://qbdgroup.com/en/services/clinical-solutions/pmpf"
---

# 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

## Plan your clinical pathway

From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey.

Contact us

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Source: https://qbdgroup.com/en/services/clinical-solutions/pmpf — © QbD Group. Quote freely with attribution and a link back.