IVDR PMPF Plans, Studies, and Reports

Under the EU In Vitro Diagnostic Regulation (IVDR 2017/746), Post-Market Performance Follow-up (PMPF) is a critical component of a manufacturer’s Post-Market Surveillance (PMS) system. IVDR PMPF is a proactive, continuous process that collects and evaluates performance data from IVD devices once they are on the market. Its purpose is to confirm the safety, scientific validity, and clinical performance of the device throughout its lifecycle.

PMPF is not optional, it is a regulatory requirement for all IVD manufacturers seeking or maintaining CE Marking. It ensures that any emerging risks are identified early and that the device continues to perform as intended in real-world settings.

Quick facts about Post Market Performance Follow-up: 

• Required under EU IVDR Annex XIII, Part B of the European IVDR (2017/746)
• Critical component of Post Market Surveillance activities
• Applies to all IVD devices, regardless of classification
• PMPF report becomes part of your Performance Evaluation Report (PER)
• Identifies emerging risks and performance trends in real-world use
• Supports continuous evaluation of scientific validity, analytical performance, and clinical performance
• Demonstrates ongoing compliance to Notified Bodies

How NAMSA Can Help You Meet PMPF Requirements

NAMSA’s team of regulatory and clinical experts—including former Notified Body professionals—offers end-to-end support for PMPF activities. We help you design and execute a compliant, efficient, and scientifically sound PMPF strategy tailored to your device and market needs.

Step 1: Strategy: Define the Right Approach

At NAMSA, we believe that a successful PMPF program starts with a well-defined strategy, not just a checklist. Before jumping into planning mode, we work closely with our clients to develop a thoughtful, risk-based approach that ensures the correct data is collected in the right way. This is essential not only for meeting IVDR requirements but also for satisfying Notified Body expectations and supporting long-term product success.

To develop your PMPF strategy, our team evaluates a range of critical factors, including:

• Device classification and intended use
• Number of devices on the market
• Existing performance and clinical data
• Scientific rationale and known limitations
• Cost, practicality, and resource availability
• Regulatory timelines and business objectives

This strategic phase is a collaborative process. We bring together NAMSA’s regulatory and clinical experts—many of whom are former Notified Body professionals—with your internal stakeholders to align on goals, priorities, and risk tolerance. Together, we define a PMPF strategy that is scientifically sound, operationally feasible, and tailored to your device’s unique profile.

Your PMPF strategy will guide key decisions about:

• The types of data to collect (e.g., literature, surveys, registry data, studies)
• The frequency and scope of PMPF activities
• Justification for the exclusion of more intensive methods (e.g., post-market studies)
• Integration with your Performance Evaluation Report (PER), PMS Plan, and Risk Management File

Step 2: Use Your Strategy To Develop An IVDR PMPF Plan

The PMPF plan is a document that outlines what PMPF activity(s) you plan to carry out for a particular device. Although the Medical Device Coordination Group (MDCG) has not issued specific guidance for PMPF plans under IVDR, best practices suggest aligning their structure closely with Post-Market Clinical Follow-up (PMCF) plans used for medical devices. NAMSA leverages this approach to ensure your PMPF Plan is comprehensive, consistent, and defensible during Notified Body review.

Your PMPF Plan will clearly outline the methods and procedures you will use to collect and evaluate post-market performance data. It will also define how you will:

• Confirm the ongoing safety, scientific validity, and clinical performance of your IVD device in real-world use
• Identify unknown side effects, emerging risks, off-label use, or systematic misuse that may not have been evident during pre-market evaluation
• Ensure that the benefit-risk ratio remains acceptable, as outlined in your risk management documentation

In many cases, post-market performance studies may not be necessary, especially for lower-risk devices or when sufficient data already exists. Instead, alternative activities such as literature reviews, user surveys, or registry data analysis may be adequate. If this is the case, NAMSA will provide a clear justification within your PMPF Plan to support this approach.

Step 3: Gather Data Via PMPF Surveys, Studies, And More As Specified In Your Plan

With a solid strategy and a compliant plan in place, the next step is to execute your PMPF activities and gather meaningful, real-world data. At NAMSA, we support you throughout the implementation phase, ensuring that your data collection methods are scientifically sound, operationally feasible, and aligned with your regulatory objectives. Our team will help you collect new PMCF data and review existing data you have available from sources including:

• PMPF surveys
• Focus groups
• Individual case reports
• Usability surveys to gather real-world input from laboratories, clinicians, or end users
• Feedback from sales or account managers
• Published literature on current “state of the art” or equivalent devices
• Registry studies to track device performance trends over time
• Full or partial scope post-market performance studies, when necessary for higher-risk or novel devices

We also help you determine when data collection can be streamlined. For many IVDs, especially those with a strong pre-market evidence base and low-risk classification, less intensive methods may be sufficient. In such cases, NAMSA will provide a clear scientific and regulatory justification to support this approach.

Conducting An IVD Performance Study

In some cases, particularly for higher-risk or innovative IVDs, conducting a post-market performance study may be necessary to generate robust, real-world evidence. These studies are designed to confirm that the device continues to meet its intended performance claims under routine conditions of use. NAMSA supports every aspect of IVD performance study execution, from protocol development and site selection to data management and regulatory reporting. Our team ensures that your study is scientifically rigorous, ethically sound, and aligned with IVDR requirements.  

Step 4: Write The PMPF Report

Once your PMPF activities are complete, the final step is to compile your findings into a structured, evidence-based PMPF Evaluation Report. This report is a critical component of your IVDR Technical Documentation and must be submitted to your Notified Body as part of your ongoing IVDR compliance.

At NAMSA, we specialize in transforming complex data into clear, defensible documentation that meets regulatory expectations. Our team ensures your PMPF Report not only summarizes your findings but also demonstrates how they support the continued safety and performance of your IVD device.

We also ensure that your report is:

• Formatted to meet Notified Body expectations, with clear traceability to your PMPF Plan
• Integrated with your broader technical documentation, including PMS and PER updates
• Supported by scientific rationale and regulatory justification, especially when no new data collection is required

If your PMPF activities reveal no significant changes or risks, NAMSA will help you clearly justify this outcome and document it appropriately. If new risks or performance concerns are identified, we’ll guide you through the necessary corrective actions and documentation updates.

Our goal is to ensure your PMPF Report not only satisfies regulatory requirements but also strengthens your overall compliance strategy and product lifecycle management.