Post-Market Performance Follow-up (PMPF) Services for IVDs (IVDR Compliance)
Our Post-Market Performance Follow-up (PMPF) services support IVD manufacturers in maintaining ongoing compliance with IVDR (EU 2017/746) requirements. Patient Guard provides expert guidance to ensure your PMPF activities continuously monitor device performance, scientific validity, and clinical benefit throughout the product lifecycle.
Post-Market Performance Follow-up (PMPF) Services
Post-Market Performance Follow-up (PMPF) is a mandatory requirement under IVDR and forms part of the Performance Evaluation process for in vitro diagnostic medical devices.
Manufacturers must proactively collect and evaluate post-market performance data to confirm scientific validity, analytical performance, and clinical performance throughout the device lifecycle.
A compliant PMPF system supports ongoing performance evaluation, risk management, vigilance, and post-market surveillance activities while demonstrating continued device safety and performance.
Patient Guard acts as your regulatory consultancy partner, supporting the development, implementation, and maintenance of compliant PMPF documentation aligned with IVDR Annex XIII and MDCG guidance.
Without a robust PMPF strategy, manufacturers risk Notified Body non-conformities, delays in certification, and increased regulatory scrutiny.
Patient Guard provides expert PMPF services tailored to your IVD technology, classification, intended purpose, and lifecycle stage.
New to the In Vitro Diagnostic Regulation (IVDR)?
This page explains Patient Guard’s Post-Market Performance Follow-up (PMPF) services, helping IVD manufacturers maintain clinical evidence and meet their ongoing obligations under Regulation (EU) 2017/746. If you're looking for a broader introduction to the IVDR, including Performance Evaluation, Scientific Validity, Analytical Performance, Clinical Performance, Risk Management, Technical Documentation and the role of PMPF throughout the IVD lifecycle, read our IVDR for Beginners – A Comprehensive Guide.
Why Choose Patient Guard for PMPF?
IVDR expertise
We align PMPF activities with IVDR, MDCG guidance, and Notified Body expectations.
Integrated lifecycle approach
We ensure PMPF outputs support performance evaluation, PMS, vigilance, and risk management processes.
Transparent pricing
Clear project-based pricing with no hidden costs.
Established regulatory consultancy
Providing expert regulatory affairs and quality assurance services since 2017.
Trusted by 500+ companies
We support global manufacturers across all IVD classifications from Class A through to Class D.
Proportionate strategies
We design compliant PMPF plans and protocols tailored precisely to your specific device risks.
What Our PMPF Service Includes
PMPF Plan Development
Creating robust, IVDR-compliant PMPF plans tailored to your device's specific technology and risk classification.
Performance Data Collection Strategy
Designing proactive methodologies to gather high-quality post-market clinical and performance data efficiently.
Literature Review & Data Analysis
Conducting systematic scientific literature reviews and rigorous analysis of real-world performance datasets.
PMPF Report Preparation
Compiling comprehensive PMPF Evaluation Reports (PMPFR) containing clear conclusions for Notified Body review.
Integration with Performance Evaluation
Ensuring seamless data flow and total alignment between your PMPF outputs and the Performance Evaluation Report (PER).
Risk Management Alignment
Linking performance data directly back to risk management documentation to verify the ongoing benefit-risk acceptability.
Trend Analysis Support
Establishing proactive screening protocols to identify and monitor statistically significant performance trends early.
Ongoing Updates & Maintenance
Providing lifecycle support to continuously maintain compliance as your device evolves in the market.
Who Requires PMPF?
- IVD manufacturers under IVDR
- Companies seeking CE marking for IVDs
- Manufacturers of Class A, B, C and D IVDs
- Organisations undergoing Notified Body review
- Companies maintaining ongoing IVDR compliance
IVDR PMPF Requirements
Under IVDR Annex XIII, manufacturers must:
- Establish and maintain PMPF procedures
- Collect and evaluate post-market performance data
- Confirm scientific validity and performance claims
- Identify emerging risks and trends
- Update Performance Evaluation documentation
- Integrate findings into PMS and vigilance systems
A compliant PMPF system is essential for demonstrating ongoing device safety, performance, and regulatory compliance.
Our Process
Step 1 – PMPF Strategy & Planning
We assess your IVD, intended purpose, and existing performance evaluation documentation to develop a compliant PMPF strategy and plan
Step 2 – Data Collection & Analysis
We support collection, review, and analysis of post-market performance data and scientific evidence
Step 3 – PMPF Reporting & Lifecycle Compliance
We prepare PMPF Reports and align outputs with performance evaluation, PMS, vigilance, and risk management documentation
Industries We Support
We support PMPF services across:
- IVD manufacturers
- Biotechnology companies
- Diagnostic developers
- Laboratory technologies
- Start-ups and global healthcare companies
Cost of Service
Post Market Performance Follow-up (PMPF) Services
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Ensure ongoing EU IVDR compliance with expert Post-Market Performance Follow-up (PMPF) support. Patient Guard develops PMPF plans, supports performance data collection, and prepares PMPF Evaluation Reports to demonstrate continued safety, performance, and benefit-risk acceptability.
Features
- IVDR-compliant PMPF Plan and PMPF Report development tailored to your IVD device
- Post-market performance data collection, literature review, and trend analysis support
- Integration of PMPF outputs with Performance Evaluation, PMS, and risk management documentation
- Ongoing regulatory and lifecycle compliance support aligned with IVDR and Notified Body expectations
Time Lines
Weeks 1–2 – PMPF Strategy & Planning
Assess your IVD, intended purpose, classification, and existing performance evaluation documentation to develop a compliant PMPF Plan
Weeks 3–6 – Data Collection & Performance Analysis
Collect and evaluate post-market performance data, scientific literature, trend information, and real-world evidence
Weeks 7–10 – PMPF Reporting & Lifecycle Compliance
Prepare the PMPF Report and align outputs with Performance Evaluation, PMS, vigilance, and risk management documentation
Frequently Asked Questions (FAQs)
What is PMPF?
Post-Market Performance Follow-up (PMPF) is the ongoing process of collecting and evaluating post-market performance data for IVDs under IVDR.
Is PMPF mandatory under IVDR?
Yes, PMPF is a mandatory component of Performance Evaluation under IVDR.
How does PMPF differ from PMS?
PMPF specifically focuses on performance evaluation and clinical evidence, while PMS covers broader post-market safety and regulatory monitoring activities.
What documentation is required for PMPF?
Manufacturers typically require a PMPF Plan and PMPF Report integrated within Performance Evaluation documentation.
How often should PMPF documentation be updated?
Updates should be performed regularly based on device classification, risk profile, and post-market findings.
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