Home » IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up

IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up

Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.

Published: 24th August 2026

Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)

Understanding IVDR Post-Market Performance Follow-up (PMPF)

Post-Market Performance Follow-up (PMPF) is one of the most important ongoing obligations introduced by the European Union In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. While Performance Evaluation demonstrates that an in vitro diagnostic medical device (IVD) achieves its intended purpose before CE marking, PMPF ensures that this evidence remains valid once the device is placed on the European market and used under real-world clinical conditions.

Rather than viewing regulatory compliance as ending once CE marking has been achieved, the IVDR adopts a lifecycle approach to device regulation. Manufacturers are expected to continually collect, review and assess post-market data to confirm that their devices continue to demonstrate acceptable scientific validity, analytical performance and clinical performance throughout their commercial life.

PMPF is therefore far more than a post-market surveillance activity. It is a proactive and systematic process designed to identify new scientific evidence, monitor device performance in routine clinical practice and determine whether the conclusions reached during the original Performance Evaluation remain appropriate. This enables manufacturers to detect emerging risks, validate existing performance claims and ensure that the benefit-risk profile of the device remains favourable as scientific knowledge and clinical practice evolve.

For many manufacturers, particularly those placing Class C and Class D IVDs on the market, PMPF represents one of the most significant ongoing regulatory responsibilities under the IVDR. However, every IVD manufacturer should consider whether post-market performance evidence is necessary to confirm the continued safety and performance of their device. The scope of PMPF should always be proportionate to the intended purpose, classification and risk profile of the device, with higher-risk IVDs generally requiring more comprehensive post-market evidence collection and analysis.

Post-Market Performance Follow-up should not be considered in isolation. It forms an integral component of the wider Performance Evaluation lifecycle and works alongside post-market surveillance (PMS), vigilance reporting and risk management to ensure that manufacturers maintain a robust understanding of how their devices perform once they are used by healthcare professionals and patients. Information gathered through PMPF may identify opportunities for product improvement, highlight changes in the current state of scientific knowledge or reveal emerging trends that require updates to the Performance Evaluation Report (PER), Risk Management File or technical documentation.

The IVDR also places increasing emphasis on the continuous generation of clinical evidence. Rather than relying solely on pre-market studies, manufacturers are expected to demonstrate that they actively monitor real-world performance throughout the device lifecycle. This approach reflects the rapidly evolving nature of diagnostic medicine, where new biomarkers, revised clinical guidelines and advances in laboratory technology may influence how an IVD is used or interpreted over time.

Ultimately, Post-Market Performance Follow-up provides ongoing confidence that an IVD continues to achieve its intended purpose after CE marking. By systematically collecting and evaluating real-world performance data, manufacturers can demonstrate continued compliance with Regulation (EU) 2017/746, support patient safety and maintain confidence in the scientific evidence underpinning their devices throughout the entire product lifecycle.

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

Post-Market Performance Follow-up (PMPF) is the continuous process of collecting, evaluating and analysing post-market data to confirm that an in vitro diagnostic medical device (IVD) continues to achieve its intended purpose after it has been placed on the market. Under Regulation (EU) 2017/746 (IVDR), PMPF forms an integral part of the manufacturer’s Performance Evaluation and provides ongoing evidence that the device remains scientifically valid, analytically reliable and clinically effective throughout its lifecycle.

The legal requirements for PMPF are established within Article 56 and Annex XIII of the IVDR, which require manufacturers to continually update their Performance Evaluation using information obtained from post-market activities. Rather than relying solely on evidence generated before CE marking, manufacturers are expected to actively monitor how their devices perform under routine clinical conditions and determine whether new information affects the conclusions previously reached.

PMPF is not intended to identify problems only after they occur. Instead, it is a proactive, planned and systematic process that helps manufacturers confirm that the assumptions made during product development remain valid in real-world use. This ongoing collection of evidence supports continual improvement, enables early identification of emerging risks and ensures that the benefit-risk profile of the device remains acceptable throughout its commercial life.

Unlike pre-market Performance Evaluation, which is largely based on planned scientific studies and validation activities, PMPF focuses on evidence generated after the device has entered routine clinical practice. This real-world evidence may identify trends, confirm existing performance claims or reveal previously unknown limitations that require further investigation.

Manufacturers should therefore regard PMPF as an extension of their original Performance Evaluation rather than a separate regulatory exercise. The information collected through PMPF should continually strengthen the overall body of evidence supporting the safety and performance of the device.

The Objectives of PMPF

The primary objective of PMPF is to confirm that an IVD continues to perform as intended throughout its lifecycle.

More specifically, PMPF helps manufacturers to:

Confirm that Scientific Validity remains current.
Verify that analytical performance continues to meet specifications.
Confirm that clinical performance remains appropriate within the intended patient population.
Identify emerging performance trends.
Detect previously unrecognised risks.
Validate the ongoing benefit-risk determination.
Support continual improvement of the device.
Demonstrate continued conformity with the IVDR.

Rather than assuming that pre-market evidence remains valid indefinitely, PMPF provides objective evidence that the device continues to meet regulatory expectations during routine clinical use.

What Types of Evidence Are Collected During PMPF?

PMPF draws upon a wide range of post-market information to evaluate whether the device continues to perform safely and effectively.

Depending on the intended purpose and classification of the device, manufacturers may collect evidence from:

Complaint investigations.
Customer feedback.
Vigilance reports.
Scientific literature.
Published clinical studies.
External Quality Assessment (EQA) programmes.
Proficiency testing schemes.
Laboratory quality indicators.
Registry data.
Clinical user surveys.
Performance trending.
Corrective and Preventive Actions (CAPA).
Internal audits where relevant.
Information provided by distributors or importers.

The type and quantity of evidence collected should always be proportionate to the device’s intended purpose, classification and associated risks.

Which Devices Require PMPF?

Every manufacturer should consider whether PMPF is necessary for their device as part of the Performance Evaluation process. The IVDR expects manufacturers to justify the scope of their PMPF activities based on the characteristics of the device and the risks associated with its intended use.

For lower-risk devices with well-established technologies and extensive existing evidence, PMPF activities may be relatively limited.

Conversely, manufacturers of Class C and Class D IVDs should generally expect to implement comprehensive PMPF programmes because these devices often influence significant clinical decisions or have implications for public health. Novel biomarkers, companion diagnostics, genetic tests and infectious disease assays may also require more extensive post-market evidence collection to confirm that pre-market conclusions remain valid.

Regardless of classification, manufacturers should be able to justify why their chosen PMPF strategy is appropriate for the device and demonstrate that it is capable of identifying new scientific or clinical information that could affect safety or performance.

PMPF Is a Continuous Lifecycle Activity

One of the most significant changes introduced by the IVDR is the expectation that Performance Evaluation continues long after CE marking has been achieved.

PMPF should therefore be viewed as a continuous lifecycle activity rather than a periodic regulatory task completed only before scheduled Notified Body audits.

Manufacturers should establish documented procedures for:

Planning PMPF activities.
Collecting post-market evidence.
Analysing performance trends.
Reviewing new scientific literature.
Assessing emerging risks.
Updating the Performance Evaluation Report (PER).
Revising the Risk Management File where necessary.
Implementing corrective actions where appropriate.

By embedding PMPF into routine quality management processes, manufacturers can ensure that new information is identified promptly and incorporated into their regulatory documentation.

How PMPF Supports Continual Improvement

Beyond demonstrating regulatory compliance, PMPF provides valuable information that can drive continual improvement throughout the product lifecycle.

Information generated during PMPF may identify opportunities to:

Improve analytical performance.
Clarify Instructions for Use.
Update performance claims.
Improve laboratory workflows.
Reduce user errors.
Optimise software algorithms.
Refine risk control measures.
Enhance future product development.

By continually learning from real-world experience, manufacturers can improve both the quality of their products and the strength of their regulatory documentation.

Ultimately, PMPF transforms Performance Evaluation from a one-time regulatory submission into a living, evidence-based process that evolves alongside scientific knowledge, clinical practice and real-world device performance.

Why IVDR PMPF Matters

Post-Market Performance Follow-up (PMPF) is far more than a regulatory obligation under the IVDR—it is a critical process that enables manufacturers to demonstrate that their in vitro diagnostic medical devices (IVDs) continue to perform safely and effectively after they have been placed on the market. While pre-market studies provide evidence that supports CE marking, they cannot anticipate every variable encountered during routine clinical use. PMPF bridges this gap by generating real-world evidence throughout the device lifecycle.

Healthcare environments, patient populations and scientific understanding are constantly evolving. New biomarkers may be discovered, clinical guidelines may change, laboratory practices may improve and new evidence may emerge that affects the interpretation or clinical significance of existing diagnostic tests. PMPF enables manufacturers to identify these developments early and determine whether they have any impact on the continued safety and performance of their devices.

By systematically collecting and evaluating post-market evidence, manufacturers can confirm that the conclusions reached during the original Performance Evaluation remain valid, while also identifying opportunities for continual improvement. This proactive approach strengthens regulatory compliance, supports patient safety and demonstrates an ongoing commitment to maintaining high standards of diagnostic performance.

Protecting Patients Through Real-World Evidence

The primary objective of every IVD is to provide reliable diagnostic information that supports appropriate clinical decision-making and ultimately protects patient health.

Although extensive validation is undertaken before CE marking, devices may perform differently once introduced into routine clinical practice. Variations in laboratory workflows, operator experience, patient demographics and clinical settings can all influence device performance.

PMPF helps manufacturers identify these real-world factors by continually monitoring evidence collected after market placement. This allows potential issues to be identified before they become widespread and helps ensure that patients continue to receive accurate and clinically meaningful diagnostic results throughout the lifecycle of the device.

Confirming Continued Scientific and Clinical Performance

Scientific knowledge does not remain static. New clinical studies are published every week, disease classifications evolve and treatment pathways are continually refined.

PMPF enables manufacturers to confirm that:

Scientific Validity remains supported by current evidence.
Analytical performance continues to meet established specifications.
Clinical performance remains appropriate for the intended patient population.
The intended purpose continues to reflect current clinical practice.

Where new evidence challenges previous assumptions, manufacturers can update their Performance Evaluation and technical documentation accordingly, ensuring that the device continues to reflect the current state of the art.

Supporting the Performance Evaluation Lifecycle

Under the IVDR, Performance Evaluation is no longer considered a one-time activity completed before CE marking. Instead, it is a continuous process that extends throughout the commercial life of the device.

PMPF provides the ongoing evidence needed to maintain and strengthen the Performance Evaluation by:

Confirming previous conclusions.
Identifying evidence gaps.
Supporting updates to the Performance Evaluation Report (PER).
Informing future analytical or clinical investigations.
Demonstrating continued conformity with the IVDR.

This lifecycle approach ensures that regulatory decisions continue to be supported by current scientific and clinical evidence rather than relying solely on historical studies.

Supporting Notified Body Review

For manufacturers of Class B, Class C and Class D IVDs, PMPF documentation forms an important part of ongoing Notified Body surveillance and recertification activities.

Notified Bodies expect manufacturers to demonstrate that they have established an appropriate PMPF programme and are actively monitoring the real-world performance of their devices.

During audits and technical documentation reviews, assessors may consider:

Whether the PMPF Plan remains appropriate.
Whether post-market evidence is being collected systematically.
Whether emerging trends have been evaluated.
Whether the Performance Evaluation Report has been updated where necessary.
Whether scientific literature is being routinely reviewed.
Whether PMPF conclusions support continued conformity.

A well-managed PMPF programme demonstrates regulatory maturity and provides confidence that the manufacturer maintains effective oversight throughout the product lifecycle.

Supporting Continued Regulatory Compliance

PMPF contributes directly to ongoing compliance with multiple aspects of Regulation (EU) 2017/746.

Information generated during PMPF supports:

Performance Evaluation.
Risk Management.
Post-Market Surveillance (PMS).
Vigilance activities.
General Safety and Performance Requirements (GSPRs).
Technical Documentation.
Quality Management System processes.

Because these regulatory activities are closely interconnected, information identified through PMPF frequently influences multiple areas of the manufacturer’s documentation.

Maintaining this alignment helps ensure that the technical documentation remains current, scientifically justified and consistent throughout the lifecycle of the device.

Driving Continual Improvement

One of the greatest benefits of PMPF is its ability to support continual improvement beyond minimum regulatory compliance.

Real-world evidence collected through PMPF may identify opportunities to:

Improve device performance.
Enhance Instructions for Use.
Reduce user errors.
Refine software algorithms.
Improve laboratory workflows.
Optimise analytical performance.
Strengthen risk control measures.
Support next-generation product development.

Rather than reacting only when problems occur, manufacturers can use PMPF data to proactively improve the quality, safety and effectiveness of their devices over time.

This continual improvement philosophy aligns closely with ISO 13485 and demonstrates a commitment to maintaining the highest standards of product performance throughout the entire device lifecycle.

PMPF versus PMS versus Vigilance

One of the most common areas of confusion under the IVDR is the relationship between Post-Market Performance Follow-up (PMPF), Post-Market Surveillance (PMS) and Vigilance. Although these activities are closely connected, they serve different regulatory purposes and should not be used interchangeably.

Manufacturers sometimes assume that collecting complaint data through their Post-Market Surveillance system automatically fulfils the requirements for PMPF. Others mistakenly believe that Vigilance reporting alone demonstrates ongoing compliance. In reality, the IVDR expects manufacturers to operate all three processes as part of an integrated post-market system, with each contributing different information to the overall assessment of device safety and performance.

A useful way to think about these activities is that PMS provides the broad framework for monitoring devices after they have been placed on the market, PMPF focuses specifically on confirming continued scientific and clinical performance, while Vigilance ensures that serious incidents and field safety corrective actions are appropriately investigated and reported.

Together, these processes help manufacturers maintain confidence in the safety, performance and regulatory compliance of their IVDs throughout the product lifecycle.

What Is Post-Market Surveillance (PMS)?

Post-Market Surveillance (PMS) is the overarching system used by manufacturers to proactively collect, analyse and evaluate information relating to the quality, performance and safety of devices once they have been placed on the market.

Under Article 78 of the IVDR, manufacturers are required to establish, document, implement and maintain a PMS system appropriate to the risk class and intended purpose of the device.

PMS collects information from a wide range of sources, including:

Customer complaints.
User feedback.
Distributor reports.
Scientific literature.
Service records.
Market trends.
Internal audits.
CAPA investigations.
Published safety information.
Competitor safety notices where relevant.

The objective of PMS is to identify opportunities for improvement, detect emerging risks and ensure that the manufacturer’s technical documentation remains current.

PMPF forms one important component of this wider PMS system.

What Is PMPF?

Post-Market Performance Follow-up focuses specifically on collecting and evaluating evidence relating to the continued performance of the device.

Rather than monitoring general quality or safety issues, PMPF asks:

“Does the device continue to achieve its intended purpose under real-world conditions?”

The information collected during PMPF helps manufacturers confirm that:

Scientific Validity remains current.
Analytical performance remains acceptable.
Clinical performance continues to support appropriate clinical decision-making.
The benefit-risk profile remains favourable.
Performance Evaluation conclusions remain valid.

PMPF therefore provides the ongoing scientific evidence needed to maintain the Performance Evaluation throughout the device lifecycle.

What Is Vigilance?

Vigilance is the regulatory process for reporting and investigating serious incidents and Field Safety Corrective Actions (FSCAs) associated with medical devices and IVDs.

Unlike PMS and PMPF, which are proactive and continuous processes, Vigilance is event-driven.

Manufacturers are required to investigate incidents that may indicate unacceptable risks associated with their devices and, where appropriate, report these events to the relevant Competent Authorities within the timeframes established by the IVDR.

Examples include:

Serious deterioration in health.
Death associated with device use.
Significant public health threats.
Incorrect diagnostic results resulting in serious consequences.
Field Safety Corrective Actions.
Product recalls where required.

Information obtained through Vigilance investigations frequently feeds back into both the PMS system and PMPF activities.

How PMPF, PMS and Vigilance Work Together

Although each process has a different objective, they should never operate independently.

Information collected through one activity often informs the others.

For example:

A complaint identified through PMS may trigger additional PMPF investigations.
PMPF may identify declining analytical performance that requires corrective action.
A serious incident reported through Vigilance may result in updates to the Risk Management File, Performance Evaluation Report and PMPF Plan.
New scientific literature identified during PMPF may influence future PMS trend analysis.
CAPA activities may be initiated following information generated by any of the three systems.

By integrating these processes, manufacturers develop a comprehensive understanding of how their devices perform throughout the product lifecycle.

Comparison Table

Activity	Primary Purpose	Typical Information Collected
Post-Market Surveillance (PMS)	Monitor the overall safety, quality and performance of the device after market placement	Complaints, customer feedback, trend analysis, literature, CAPA, audits, service data
Post-Market Performance Follow-up (PMPF)	Confirm that the device continues to achieve its intended purpose and maintain Scientific Validity, analytical performance and clinical performance	Scientific literature, clinical evidence, laboratory performance data, External Quality Assessment (EQA), registry data, user feedback, performance trends
Vigilance	Investigate and report serious incidents and Field Safety Corrective Actions	Serious incidents, adverse events, Field Safety Corrective Actions (FSCAs), recalls, Competent Authority reporting

Why Understanding the Difference Matters

Clearly distinguishing between PMS, PMPF and Vigilance helps manufacturers develop compliant post-market systems and avoid one of the most common misunderstandings identified during regulatory assessments.

Manufacturers should ensure that:

Their PMS procedures describe how post-market information will be collected and analysed.
Their PMPF Plan defines how ongoing performance evidence will be generated and evaluated.
Their Vigilance procedures establish how reportable incidents will be investigated and communicated to Competent Authorities.
Information flows effectively between all three systems.
Updates to the Performance Evaluation, Risk Management File and technical documentation are made whenever new evidence warrants revision.

By treating PMPF, PMS and Vigilance as complementary components of a single post-market strategy, manufacturers can maintain robust regulatory compliance while continually improving the safety and performance of their devices.

Legal Requirements for PMPF Under the IVDR

Post-Market Performance Follow-up (PMPF) is not simply considered best practice under the IVDR—it is a legal requirement that forms part of the manufacturer’s ongoing obligation to demonstrate that an in vitro diagnostic medical device (IVD) continues to achieve its intended purpose after CE marking. Regulation (EU) 2017/746 establishes a lifecycle approach to regulatory compliance, requiring manufacturers to continually review new scientific evidence, monitor real-world device performance and update their Performance Evaluation whenever necessary.

Unlike the previous In Vitro Diagnostic Directive (IVDD), which placed relatively limited emphasis on the collection of post-market performance evidence, the IVDR introduces significantly more robust requirements. Manufacturers are now expected to actively generate, analyse and document post-market performance data throughout the commercial life of their devices, ensuring that the scientific evidence supporting the Performance Evaluation remains current and reflects the latest state of the art.

Several provisions within the IVDR work together to establish these obligations, making PMPF an integral part of the wider regulatory framework.

Article 56 – Performance Evaluation

Article 56 establishes the overarching requirement for manufacturers to demonstrate that their devices achieve the performance intended by the manufacturer and continue to comply with the applicable General Safety and Performance Requirements (GSPRs).

To achieve this, manufacturers must establish and maintain a Performance Evaluation based upon three interconnected components:

Scientific Validity.
Analytical Performance.
Clinical Performance.

Importantly, Article 56 also requires manufacturers to ensure that the Performance Evaluation is continuously updated using information generated throughout the device lifecycle.

PMPF provides one of the principal mechanisms for maintaining this ongoing Performance Evaluation by collecting real-world evidence after market placement and determining whether the original conclusions remain valid.

Annex XIII – Performance Evaluation and PMPF

Annex XIII provides the detailed regulatory requirements for Performance Evaluation and Post-Market Performance Follow-up.

The Annex explains that PMPF should be a continuous process through which manufacturers proactively collect and evaluate performance data obtained after CE marking.

The objectives of PMPF include confirming:

Continued Scientific Validity.
Continued analytical performance.
Continued clinical performance.
Continued acceptability of the benefit-risk ratio.
Continued conformity with the General Safety and Performance Requirements.

Annex XIII also expects manufacturers to identify any emerging risks, performance limitations or changes in scientific understanding that could influence the continued safety and performance of the device.

Where new information becomes available, manufacturers should determine whether updates to the Performance Evaluation Report (PER), Risk Management File or technical documentation are necessary.

The PMPF Plan

The IVDR requires manufacturers to establish a documented PMPF Plan describing how post-market performance evidence will be collected and evaluated.

The PMPF Plan should be proportionate to the intended purpose, risk class and complexity of the device.

Although the precise format may vary, a comprehensive PMPF Plan typically includes:

The objectives of the PMPF programme.
The types of data that will be collected.
Sources of post-market evidence.
Methods for analysing the data.
Acceptance criteria where appropriate.
Review frequencies.
Responsibilities within the organisation.
Procedures for updating the Performance Evaluation.

The PMPF Plan should not be regarded as a static document. It should be reviewed periodically and revised whenever changes to the device, intended purpose or scientific evidence make updates necessary.

The PMPF Report

The results of PMPF activities should be documented within a PMPF Report.

The report provides evidence that the activities described within the PMPF Plan have been completed and summarises the conclusions reached from the analysis of post-market performance data.

A typical PMPF Report may include:

A summary of PMPF activities completed.
Scientific literature reviewed.
Complaint and trend analysis.
Performance data collected.
External Quality Assessment (EQA) findings where applicable.
Conclusions regarding Scientific Validity.
Conclusions regarding analytical performance.
Conclusions regarding clinical performance.
Assessment of the benefit-risk profile.
Recommendations for updates to the Performance Evaluation.

The report should provide sufficient detail to demonstrate that post-market evidence has been systematically evaluated and that the conclusions remain scientifically justified.

Maintaining the Performance Evaluation Report (PER)

One of the key purposes of PMPF is to ensure that the Performance Evaluation Report remains current throughout the lifecycle of the device.

Whenever significant new evidence is identified, manufacturers should determine whether updates are required to:

The Performance Evaluation Report (PER).
Scientific Validity assessment.
Analytical performance conclusions.
Clinical performance conclusions.
Risk Management File.
Intended purpose.
Instructions for Use (IFU).
Performance claims.

This continuous review process helps ensure that regulatory documentation reflects the latest available scientific and clinical evidence rather than relying solely on pre-market studies.

Relationship with the Quality Management System

Manufacturers should integrate PMPF into their Quality Management System (QMS), typically implemented in accordance with ISO 13485.

Relevant QMS procedures include:

Document control.
Change management.
Complaint handling.
Post-Market Surveillance.
Risk management.
CAPA.
Management review.
Internal audits.

Integrating PMPF into these established quality processes ensures that post-market evidence is reviewed consistently, appropriate actions are implemented promptly and regulatory documentation remains under effective change control.

Expectations During Notified Body Assessments

For devices requiring Notified Body involvement, PMPF documentation forms an important part of both initial conformity assessment and ongoing surveillance activities.

Notified Bodies will generally expect manufacturers to demonstrate that they have:

Established an appropriate PMPF Plan.
Implemented the activities described within the plan.
Collected relevant post-market performance evidence.
Reviewed current scientific literature.
Analysed trends objectively.
Updated the Performance Evaluation where appropriate.
Maintained traceability throughout the technical documentation.

Assessors are unlikely to focus solely on whether a PMPF Report exists. Instead, they will evaluate whether the PMPF programme is genuinely effective in monitoring real-world device performance and supporting continual regulatory compliance.

Manufacturers who adopt a proactive and well-documented approach to PMPF are generally better positioned to respond efficiently to regulatory questions and demonstrate continued conformity with Regulation (EU) 2017/746 throughout the lifecycle of their IVDs.

Developing a PMPF Plan

A Post-Market Performance Follow-up (PMPF) Plan is the foundation of an effective PMPF programme. It sets out how the manufacturer intends to collect, evaluate and use post-market performance evidence to confirm that an in vitro diagnostic medical device (IVD) continues to achieve its intended purpose throughout its lifecycle.

Rather than reacting to problems after they occur, the PMPF Plan establishes a proactive strategy for monitoring the continued scientific validity, analytical performance and clinical performance of the device under routine conditions of use. It should clearly define the objectives of the PMPF programme, identify the sources of evidence to be collected and describe how that information will be analysed and incorporated into the manufacturer’s regulatory documentation.

The IVDR does not prescribe a mandatory PMPF Plan template, allowing manufacturers flexibility to develop documentation appropriate to the complexity and risk profile of their devices. However, regardless of format, the plan should demonstrate that PMPF activities have been carefully considered, are proportionate to the device and are capable of identifying changes that may affect the continued safety or performance of the IVD.

For many manufacturers, the PMPF Plan becomes one of the key documents reviewed by Notified Bodies during conformity assessment and subsequent surveillance audits.

Defining the Objectives of the PMPF Programme

The first step in developing a PMPF Plan is to clearly define what the programme is intended to achieve.

While every PMPF programme aims to confirm continued conformity with the IVDR, individual objectives will vary depending on the intended purpose, classification and technological characteristics of the device.

Typical objectives include:

Confirming that Scientific Validity remains supported by current evidence.
Confirming continued analytical performance under routine conditions.
Confirming continued clinical performance in the intended patient population.
Identifying emerging trends affecting device performance.
Detecting previously unidentified risks.
Verifying that the benefit-risk profile remains favourable.
Supporting updates to the Performance Evaluation Report (PER).
Demonstrating continued conformity with Regulation (EU) 2017/746.

Clearly defined objectives provide direction for the entire PMPF programme and help ensure that evidence collection remains focused on the questions most relevant to the continued safety and performance of the device.

Identifying Appropriate Data Sources

A robust PMPF programme should collect evidence from multiple complementary sources rather than relying on a single type of post-market information.

Depending on the characteristics of the device, manufacturers may include data from:

Customer complaints.
User feedback.
Scientific literature.
Published clinical studies.
External Quality Assessment (EQA) schemes.
Proficiency testing programmes.
Registry data.
Laboratory performance monitoring.
Customer surveys.
Technical support records.
Service reports.
Distributor feedback.
Vigilance investigations.
Trend analysis from Post-Market Surveillance (PMS).

Using multiple evidence sources enables manufacturers to build a comprehensive picture of how the device performs under real-world conditions and reduces the likelihood that important performance trends will be overlooked.

Determining the Frequency of PMPF Activities

The PMPF Plan should define how often post-market evidence will be collected, reviewed and analysed.

The review frequency should be proportionate to the risks associated with the device and should take into account factors such as:

Device classification.
Intended purpose.
Clinical significance of the test result.
Novelty of the technology.
Existing scientific evidence.
Volume of devices placed on the market.
Previous post-market experience.

For higher-risk devices or rapidly evolving technologies, manufacturers may review PMPF data more frequently to ensure that emerging issues are identified promptly.

The PMPF Plan should also describe the circumstances that would trigger an unscheduled review, such as significant safety concerns, publication of important new scientific evidence or changes to clinical practice guidelines.

Establishing Roles and Responsibilities

An effective PMPF programme requires clearly defined responsibilities within the organisation.

The PMPF Plan should identify who is responsible for:

Collecting post-market data.
Reviewing scientific literature.
Analysing performance trends.
Updating the Performance Evaluation Report.
Maintaining the PMPF Report.
Reviewing risk management documentation.
Implementing corrective actions where necessary.
Approving updates to technical documentation.

Defining responsibilities ensures accountability and helps demonstrate that PMPF activities are fully integrated into the manufacturer’s Quality Management System.

Defining Evaluation Criteria

Collecting post-market data is only valuable if manufacturers understand how it will be evaluated.

The PMPF Plan should establish predefined criteria describing how evidence will be interpreted and when further investigation may be required.

Examples include:

Unexpected increases in complaint rates.
Significant changes in diagnostic accuracy.
New scientific publications affecting Scientific Validity.
Declining laboratory performance.
Emerging trends identified through proficiency testing.
Updated international clinical guidelines.
Increased frequency of user errors.
New safety concerns identified through Vigilance.

Having predefined evaluation criteria helps ensure that evidence is assessed objectively and consistently rather than relying on subjective judgement.

Linking PMPF to Other Regulatory Activities

PMPF should not operate as an isolated process.

The PMPF Plan should clearly describe how information generated through PMPF will influence other elements of the manufacturer’s regulatory system.

These links typically include:

Performance Evaluation Report (PER).
Scientific Validity assessment.
Analytical performance documentation.
Clinical performance documentation.
Risk Management File.
Post-Market Surveillance (PMS).
Vigilance procedures.
CAPA system.
Technical Documentation.
Management Review.
Design and development activities.

Maintaining these links ensures that new evidence identified during PMPF is reflected consistently throughout the manufacturer’s documentation and quality management processes.

Reviewing and Updating the PMPF Plan

The PMPF Plan should itself be regarded as a living document.

Manufacturers should review the plan periodically to ensure that it continues to reflect:

The current state of scientific knowledge.
Changes to the intended purpose.
Device design modifications.
New regulatory guidance.
Updated clinical practice.
Lessons learned from previous PMPF activities.
Findings arising from Post-Market Surveillance or Vigilance.

Whenever significant changes occur, the PMPF Plan should be updated to ensure that future post-market activities remain appropriate and proportionate.

By maintaining an up-to-date PMPF Plan, manufacturers demonstrate that they are actively managing post-market performance rather than simply complying with a regulatory documentation requirement.

Generating PMPF Evidence

The success of any Post-Market Performance Follow-up (PMPF) programme depends on the quality and relevance of the evidence collected after an in vitro diagnostic medical device (IVD) has been placed on the market. A well-designed PMPF Plan establishes what information should be collected, but it is the ongoing generation and evaluation of post-market evidence that enables manufacturers to demonstrate continued compliance with Regulation (EU) 2017/746.

Unlike pre-market Performance Evaluation, which relies heavily on planned validation studies, PMPF focuses on understanding how a device performs during routine clinical use. This real-world evidence provides valuable insight into whether the device continues to achieve its intended purpose across different laboratories, patient populations and healthcare settings.

The IVDR does not prescribe a single method for generating PMPF evidence. Instead, manufacturers are expected to adopt a proportionate approach based on the intended purpose, risk classification and complexity of their device. In most cases, the strongest PMPF programmes combine evidence from multiple independent sources, allowing manufacturers to build a comprehensive understanding of device performance throughout its lifecycle.

Reviewing Scientific Literature

One of the most valuable sources of PMPF evidence is the ongoing review of published scientific literature.

Scientific understanding continually evolves as new clinical studies, systematic reviews, consensus statements and clinical guidelines are published. Regular literature reviews help manufacturers determine whether:

New evidence supports existing Scientific Validity.
Emerging research challenges previous conclusions.
Clinical practice has changed.
New biomarkers have become available.
Alternative diagnostic approaches have emerged.
Updated guidelines affect the intended purpose of the device.

Rather than performing a single literature review during product development, manufacturers should establish procedures for periodically reviewing new publications throughout the commercial life of the device.

This helps ensure that the Performance Evaluation remains aligned with the current state of scientific knowledge.

Monitoring Complaint and Customer Feedback

Complaints and customer feedback provide valuable real-world information about how an IVD performs during routine use.

Manufacturers should analyse complaint data to identify trends that may indicate:

Reduced analytical performance.
User misunderstandings.
Labelling issues.
Software usability concerns.
Unexpected performance limitations.
Device failures affecting diagnostic accuracy.

Customer feedback can also highlight opportunities for product improvement before more significant issues develop.

Importantly, complaint trends should be evaluated alongside other PMPF evidence rather than in isolation, as individual complaints may not accurately reflect overall device performance.

External Quality Assessment (EQA) and Proficiency Testing

Participation in External Quality Assessment (EQA) schemes and proficiency testing programmes provides objective evidence of analytical performance under routine laboratory conditions.

These programmes compare the performance of multiple laboratories using the same test materials, allowing manufacturers to assess whether their devices continue to produce accurate and reproducible results across different users and clinical environments.

EQA findings may help identify:

Analytical drift.
Calibration issues.
Reproducibility concerns.
Laboratory-to-laboratory variation.
Emerging performance trends.

For many higher-risk IVDs, EQA participation provides particularly valuable PMPF evidence because it reflects independent assessment under real-world conditions.

Analysing Laboratory Performance Data

Many manufacturers collect anonymised performance data from laboratories using their devices.

Examples include:

Quality control results.
Instrument performance logs.
Error rates.
Invalid test frequencies.
Repeat testing rates.
Calibration performance.
Turnaround times where relevant.

Trend analysis of laboratory performance data can provide early warning of declining analytical performance or identify opportunities to improve product design, software functionality or user guidance.

Manufacturers should ensure that appropriate data protection and confidentiality requirements are maintained whenever laboratory data is collected and analysed.

Reviewing Registry and Clinical Data

Clinical registries and real-world healthcare databases can provide valuable evidence supporting continued clinical performance.

Depending on the intended purpose of the device, manufacturers may review:

Disease registries.
National screening programme data.
Hospital outcome databases.
Public health surveillance programmes.
Longitudinal observational studies.
Published clinical audits.

These data sources help confirm that diagnostic results continue to support appropriate clinical decision-making within the intended patient population.

For innovative technologies or companion diagnostics, registry data may become an increasingly important source of long-term PMPF evidence.

Evaluating Vigilance and Post-Market Surveillance Data

Although PMPF is distinct from Post-Market Surveillance (PMS) and Vigilance, both activities generate valuable evidence that should be incorporated into the PMPF programme.

Manufacturers should evaluate:

Serious incident investigations.
Field Safety Corrective Actions (FSCAs).
Safety notices.
Trend reports.
CAPA investigations.
Root cause analyses.

This information helps determine whether safety-related events also affect the continued performance of the device and whether updates to the Performance Evaluation or Risk Management File are required.

Gathering Feedback from Healthcare Professionals

Healthcare professionals often provide valuable practical insights that are not captured through formal complaint systems.

Manufacturers may obtain feedback through:

User surveys.
Scientific advisory boards.
Clinical collaborations.
Customer interviews.
Distributor feedback.
Technical support interactions.
Training events.

This information can help identify:

Emerging clinical needs.
Usability improvements.
Workflow challenges.
Interpretation issues.
Opportunities for product enhancement.

Although subjective feedback should not replace objective scientific evidence, it can provide valuable context when interpreted alongside other PMPF data.

Combining Multiple Sources of Evidence

No single source of post-market information is likely to provide sufficient evidence to support ongoing Performance Evaluation.

Instead, manufacturers should integrate information from multiple complementary sources to develop a balanced understanding of real-world device performance.

For example, declining analytical performance identified through External Quality Assessment may be investigated alongside complaint trends, published scientific literature and laboratory quality control data. Similarly, updates to international clinical guidelines may prompt manufacturers to review Scientific Validity, assess new literature and determine whether changes to the intended purpose or Performance Evaluation Report are required.

By combining evidence from multiple independent sources, manufacturers can identify meaningful trends more reliably, respond proactively to emerging issues and maintain a scientifically robust Performance Evaluation throughout the device lifecycle.

Ultimately, generating high-quality PMPF evidence enables manufacturers to demonstrate that their IVD continues to meet the requirements of the IVDR long after CE marking has been achieved. This evidence supports informed regulatory decision-making, continual improvement and ongoing confidence in the safety and performance of the device.

Preparing a PMPF Report

The Post-Market Performance Follow-up (PMPF) Report is the formal record of the manufacturer’s post-market performance activities and demonstrates how the evidence collected through the PMPF programme supports the continued safety, performance and regulatory compliance of an in vitro diagnostic medical device (IVD). It provides objective evidence that the manufacturer has systematically evaluated real-world data, assessed whether the original Performance Evaluation remains valid and taken appropriate action where new information has emerged.

Unlike the PMPF Plan, which describes how post-market evidence will be collected, the PMPF Report documents what has actually been done, what evidence has been reviewed and the conclusions reached. Together, these documents demonstrate that PMPF is an active and ongoing process rather than simply a regulatory requirement documented within the technical file.

For many manufacturers, particularly those of Class C and Class D IVDs, the PMPF Report becomes one of the key documents reviewed during Notified Body surveillance activities because it demonstrates that the Performance Evaluation continues to be supported by current scientific and clinical evidence.

The Purpose of a PMPF Report

The primary purpose of the PMPF Report is to evaluate whether the conclusions reached during the original Performance Evaluation remain valid following analysis of post-market evidence.

More specifically, the report should demonstrate whether:

Scientific Validity remains current.
Analytical performance continues to meet the manufacturer’s specifications.
Clinical performance continues to support the intended purpose.
The benefit-risk profile remains acceptable.
New risks or performance trends have been identified.
Updates to the technical documentation are required.

Rather than simply presenting collected data, the PMPF Report should explain what the evidence means and whether it has any impact on the continued conformity of the device.

What Should a PMPF Report Include?

Although the IVDR does not prescribe a mandatory report template, a comprehensive PMPF Report will typically include:

Device identification.
Intended purpose.
Scope of the PMPF activities.
Reference to the approved PMPF Plan.
Reporting period.
Summary of PMPF activities completed.
Sources of evidence reviewed.
Scientific literature reviewed.
Complaint and trend analysis.
External Quality Assessment (EQA) findings.
Clinical performance observations.
Risk evaluation.
Assessment of the benefit-risk profile.
Overall conclusions.
Recommendations for updates to the Performance Evaluation or technical documentation.

The report should present the evidence in a logical and traceable manner, allowing regulators and Notified Bodies to understand how conclusions have been reached.

Evaluating the Evidence

A PMPF Report should not simply describe the information collected during the reporting period.

Instead, manufacturers should critically evaluate the evidence by considering:

Whether performance trends have changed.
Whether complaint rates remain acceptable.
Whether new scientific literature affects Scientific Validity.
Whether laboratory performance remains consistent.
Whether clinical practice has evolved.
Whether new risks have emerged.
Whether previous assumptions remain justified.

This critical evaluation is one of the most important elements of the report because it demonstrates that manufacturers are actively reviewing post-market evidence rather than simply collecting data.

Where no significant changes have been identified, the report should explain why the available evidence supports the conclusion that the original Performance Evaluation remains valid.

Maintaining Traceability

One of the most important characteristics of an effective PMPF Report is clear traceability.

Manufacturers should be able to demonstrate how information generated during PMPF influences other elements of the technical documentation.

Typical traceability includes links between the PMPF Report and:

Performance Evaluation Report (PER).
Scientific Validity assessment.
Analytical performance documentation.
Clinical performance documentation.
Risk Management File.
General Safety and Performance Requirements (GSPR) checklist.
Instructions for Use (IFU).
Post-Market Surveillance (PMS) documentation.

Maintaining these links helps demonstrate that PMPF findings have been fully considered throughout the regulatory documentation rather than existing as an isolated report.

Documenting Actions and Improvements

An effective PMPF programme should result in meaningful regulatory decisions.

Where new evidence identifies opportunities for improvement, the PMPF Report should document:

Corrective actions implemented.
Preventive actions initiated.
Updates to performance claims.
Revisions to the Instructions for Use.
Changes to the Risk Management File.
Updates to the Performance Evaluation Report.
Design improvements where appropriate.
Additional studies planned.

Equally important, where no action is considered necessary, the report should clearly explain the rationale supporting that decision.

This demonstrates that post-market evidence has been objectively evaluated and appropriate regulatory decisions have been made.

Reviewing and Approving the PMPF Report

Like all controlled quality records, the PMPF Report should be subject to formal review and approval within the manufacturer’s Quality Management System.

Typical review activities include:

Verification that all planned PMPF activities have been completed.
Confirmation that evidence has been evaluated objectively.
Review of scientific conclusions.
Assessment of proposed actions.
Approval by appropriately authorised personnel.
Document control and version management.

Maintaining effective document control helps demonstrate compliance with ISO 13485 and ensures that the most current version of the PMPF Report is available for regulatory review.

Preparing for Notified Body Review

For devices requiring Notified Body assessment, the PMPF Report provides important evidence that the manufacturer continues to monitor device performance following CE marking.

During technical documentation reviews or surveillance audits, Notified Bodies may evaluate whether:

The PMPF Plan has been implemented as intended.
Appropriate evidence sources have been reviewed.
Scientific literature has been updated.
Complaint and trend data have been analysed.
Conclusions are supported by objective evidence.
Traceability has been maintained throughout the technical documentation.
Updates have been made where new information justified regulatory action.

Manufacturers who prepare well-structured, evidence-based PMPF Reports are generally able to demonstrate continued conformity more efficiently and respond more effectively to regulatory questions during surveillance activities.

Ultimately, the PMPF Report provides documented evidence that the manufacturer continues to understand how the device performs in real-world clinical practice and remains committed to maintaining compliance throughout the entire lifecycle of the IVD.

Common PMPF Mistakes

Post-Market Performance Follow-up (PMPF) is intended to be a proactive and evidence-based process that demonstrates the continued safety and performance of an in vitro diagnostic medical device (IVD). However, many manufacturers struggle to implement PMPF effectively, often treating it as a documentation exercise rather than an ongoing regulatory activity.

During conformity assessments and surveillance audits, Notified Bodies frequently identify deficiencies that reduce confidence in the manufacturer’s ability to monitor device performance throughout its lifecycle. In many cases, these shortcomings are not caused by a lack of post-market information but by weaknesses in planning, documentation or the interpretation of the evidence collected.

Understanding these common mistakes can help manufacturers develop more robust PMPF programmes and avoid unnecessary delays during regulatory review.

Treating PMPF as a One-Time Activity

One of the most common misunderstandings is viewing PMPF as a report that is produced once after CE marking and then archived until the next surveillance audit.

The IVDR clearly establishes PMPF as a continuous lifecycle activity that should evolve alongside the device, scientific knowledge and clinical practice.

Manufacturers should continually review:

New scientific literature.
Clinical guidelines.
Performance trends.
Complaint data.
Laboratory feedback.
Emerging risks.

A PMPF programme that remains unchanged for several years is unlikely to demonstrate the proactive approach expected under Regulation (EU) 2017/746.

Confusing PMPF with Post-Market Surveillance (PMS)

Many manufacturers assume that a functioning Post-Market Surveillance (PMS) system automatically fulfils the requirements for PMPF.

Although the two activities are closely related, they have different objectives.

PMS focuses on monitoring the overall safety, quality and performance of the device, while PMPF specifically evaluates whether the device continues to achieve its intended purpose by confirming:

Continued Scientific Validity.
Continued analytical performance.
Continued clinical performance.

A PMPF programme that consists solely of complaint summaries or PMS trend reports is unlikely to satisfy the expectations of Notified Bodies.

Relying Only on Complaint Data

Complaint handling provides valuable information, but complaints alone rarely provide sufficient evidence to demonstrate continued performance.

Manufacturers should collect evidence from multiple complementary sources, including:

Scientific literature.
External Quality Assessment (EQA) schemes.
Proficiency testing.
Laboratory performance monitoring.
Clinical registries.
User feedback.
Published clinical studies.
Vigilance investigations.

Using diverse evidence sources provides a much more reliable assessment of real-world device performance than complaint data alone.

Failing to Review New Scientific Evidence

Scientific understanding continually evolves throughout the commercial life of an IVD.

Some manufacturers prepare comprehensive literature reviews before CE marking but fail to monitor new publications afterwards.

This may result in:

Outdated Scientific Validity assessments.
Performance claims that no longer reflect current knowledge.
Missed opportunities to strengthen the evidence base.
Failure to identify emerging diagnostic approaches.

Regular literature reviews should form a routine part of every PMPF programme and should be documented within the PMPF Report.

Poor Traceability Between Regulatory Documents

PMPF findings should influence numerous elements of the manufacturer’s technical documentation.

A common deficiency identified during regulatory review is poor traceability between the PMPF Report and documents such as:

Performance Evaluation Report (PER).
Scientific Validity assessment.
Risk Management File.
General Safety and Performance Requirements (GSPR) checklist.
Instructions for Use (IFU).
Clinical performance documentation.

If new evidence is identified during PMPF but is not reflected elsewhere within the technical documentation, regulators may question whether the evidence has been adequately evaluated.

Maintaining clear traceability demonstrates that PMPF is fully integrated into the manufacturer’s Quality Management System rather than existing as an isolated activity.

Failing to Document Decisions

Another common weakness is documenting the evidence collected without explaining the regulatory decisions that resulted from the review.

A PMPF Report should clearly explain:

What evidence was evaluated.
What conclusions were reached.
Whether any risks were identified.
Whether updates to the technical documentation were required.
Why corrective actions were or were not implemented.

Simply stating that “no issues were identified” provides little assurance unless supported by a documented evaluation of the evidence.

Transparent decision-making demonstrates that the PMPF programme is actively managed rather than passively maintained.

Applying the Same PMPF Programme to Every Device

Manufacturers sometimes use identical PMPF Plans for every device regardless of classification, intended purpose or technological complexity.

The IVDR expects PMPF activities to be proportionate to the characteristics of the device.

For example:

A well-established Class A laboratory reagent may require relatively limited PMPF activities.
A novel companion diagnostic or Class D infectious disease assay is likely to require significantly more comprehensive post-market evidence collection.
Devices incorporating artificial intelligence or rapidly evolving biomarkers may require more frequent literature reviews and closer monitoring of clinical performance.

Tailoring the PMPF programme to the individual device demonstrates that the manufacturer has adopted a risk-based approach consistent with the principles of the IVDR.

Failing to Update the Performance Evaluation

The ultimate purpose of PMPF is not simply to collect information but to determine whether the original Performance Evaluation remains valid.

Where significant new evidence becomes available, manufacturers should assess whether updates are required to:

Scientific Validity.
Analytical performance.
Clinical performance.
Performance Evaluation Report (PER).
Risk Management File.
Instructions for Use.
Performance claims.
Technical Documentation.

Failure to update these documents when warranted may indicate that the PMPF programme is not functioning effectively.

Key Takeaways

Many PMPF deficiencies can be avoided by adopting a structured, proactive and evidence-based approach throughout the device lifecycle.

Before finalising your PMPF Report, ask the following questions:

✔ Is the PMPF programme proportionate to the device?

✔ Have multiple sources of post-market evidence been evaluated?

✔ Has new scientific literature been reviewed?

✔ Have performance trends been critically analysed?

✔ Have all regulatory decisions been documented?

✔ Is there clear traceability throughout the technical documentation?

✔ Has the Performance Evaluation Report been updated where necessary?

✔ Does the PMPF programme demonstrate continual improvement?

By treating PMPF as a continuous regulatory process rather than a periodic reporting exercise, manufacturers can strengthen their Performance Evaluation, improve regulatory compliance and demonstrate continued confidence in the safety and performance of their devices throughout their commercial lifecycle.

PMPF Within Your IVDR Regulatory Strategy

Post-Market Performance Follow-up (PMPF) should never be considered an isolated regulatory activity. Instead, it forms part of an integrated regulatory strategy that supports the continued safety, performance and compliance of an in vitro diagnostic medical device (IVD) throughout its entire lifecycle. The information generated through PMPF influences numerous elements of the manufacturer’s technical documentation and quality management system, ensuring that regulatory decisions continue to be supported by current scientific and clinical evidence.

Manufacturers who successfully integrate PMPF into their wider regulatory strategy are generally better positioned to maintain compliance with Regulation (EU) 2017/746, respond efficiently to Notified Body questions and demonstrate that their devices continue to achieve their intended purpose after CE marking.

Rather than producing a PMPF Report simply to satisfy a regulatory requirement, manufacturers should use PMPF as a continual source of evidence that supports informed decision-making across every stage of the product lifecycle.

Supporting the Performance Evaluation Report (PER)

The Performance Evaluation Report (PER) is one of the most important documents within the technical documentation because it demonstrates that the device continues to meet the performance requirements of the IVDR.

PMPF plays a central role in maintaining the PER by providing new evidence obtained after market placement.

Information generated through PMPF may:

Confirm previous Performance Evaluation conclusions.
Strengthen existing evidence.
Identify new scientific publications.
Highlight changes in clinical practice.
Reveal emerging performance trends.
Support revisions to analytical or clinical performance conclusions.

Rather than preparing entirely new Performance Evaluation Reports, manufacturers should continually update the PER using relevant findings from PMPF activities, ensuring that the document reflects the most current evidence available.

Maintaining Scientific Validity

Scientific knowledge evolves continuously throughout the commercial life of an IVD.

New biomarkers may be identified, disease classifications may change and international clinical guidelines are regularly updated.

PMPF provides the mechanism for monitoring these developments and determining whether the original Scientific Validity assessment remains appropriate.

Manufacturers should routinely assess whether:

New scientific publications support existing conclusions.
Alternative biomarkers have emerged.
Updated clinical guidelines influence the intended purpose.
New evidence challenges previously accepted scientific understanding.
The current state of the art has evolved.

Where necessary, the Scientific Validity assessment should be revised to ensure that the Performance Evaluation continues to reflect current scientific knowledge.

Supporting Risk Management

PMPF and risk management are closely interconnected.

The real-world evidence generated through PMPF may identify previously unrecognised hazards, confirm existing risk estimates or demonstrate that current risk control measures continue to be effective.

Examples include:

Increased frequencies of invalid test results.
New sources of analytical interference.
Changes in laboratory workflows.
Unexpected patterns of user error.
Emerging clinical limitations.

Where significant findings are identified, manufacturers should review the Risk Management File in accordance with ISO 14971 and determine whether:

New hazards should be identified.
Existing risk estimates require revision.
Additional risk controls are necessary.
The benefit-risk determination remains acceptable.

Maintaining this link demonstrates that post-market evidence is actively informing the manufacturer’s risk management activities rather than being considered separately.

Supporting Post-Market Surveillance (PMS)

Although PMPF and Post-Market Surveillance (PMS) are distinct activities, they should operate as complementary parts of a single post-market strategy.

PMS provides broad oversight of device safety, quality and performance, while PMPF focuses specifically on confirming continued performance against the intended purpose.

Information generated through PMS often provides valuable inputs into PMPF, including:

Complaint trends.
Customer feedback.
Distributor reports.
Service information.
Trend analyses.
Corrective and Preventive Actions (CAPA).
Vigilance investigations.

Similarly, PMPF findings may trigger updates to the PMS system where new risks or performance trends are identified.

Integrating these activities improves the consistency of post-market decision-making and helps manufacturers maintain a comprehensive understanding of device performance.

Supporting the Quality Management System

An effective PMPF programme should be fully integrated into the manufacturer’s Quality Management System (QMS), typically implemented in accordance with ISO 13485.

Relevant quality processes include:

Document control.
Change management.
Design and development.
Complaint handling.
CAPA.
Internal audits.
Management review.
Supplier management where appropriate.
Training and competence management.

Embedding PMPF within the QMS helps ensure that post-market evidence is collected consistently, reviewed appropriately and incorporated into controlled regulatory documentation.

It also demonstrates that PMPF activities remain subject to effective oversight and continual improvement.

Supporting Technical Documentation

The IVDR requires manufacturers to maintain technical documentation throughout the lifecycle of the device.

PMPF provides much of the evidence required to demonstrate that this documentation remains current.

Findings arising from PMPF may influence:

Intended Purpose.
Performance Evaluation Report (PER).
Scientific Validity assessment.
Analytical Performance documentation.
Clinical Performance documentation.
Risk Management File.
General Safety and Performance Requirements (GSPR) Checklist.
Instructions for Use (IFU).
Labelling where appropriate.

Maintaining consistency across these documents demonstrates that the manufacturer’s regulatory system is actively managed rather than relying solely on information generated before CE marking.

Supporting Continual Improvement

One of the greatest strengths of PMPF is its contribution to continual improvement.

By systematically reviewing real-world evidence, manufacturers can identify opportunities to:

Improve analytical performance.
Enhance software functionality.
Clarify user instructions.
Optimise laboratory workflows.
Reduce user error.
Strengthen risk control measures.
Improve future product development.

This continual improvement approach aligns closely with both the IVDR and ISO 13485, demonstrating that the manufacturer remains committed to maintaining the highest standards of quality and performance throughout the entire product lifecycle.

Rather than being viewed solely as a compliance activity, PMPF should be regarded as a valuable source of knowledge that drives ongoing innovation, strengthens regulatory confidence and supports the delivery of safe, effective and reliable diagnostic devices.

Real-World PMPF Examples

Every Post-Market Performance Follow-up (PMPF) programme should be tailored to the intended purpose, classification and risk profile of the in vitro diagnostic medical device (IVD). Although the underlying principles remain consistent across all devices, the types of evidence collected and the scope of post-market activities can vary considerably depending on the technology involved and the clinical decisions supported by the device.

The following examples illustrate how PMPF may be implemented for different categories of IVDs. They are intended to demonstrate the practical application of PMPF under the IVDR rather than prescribe specific regulatory requirements for individual devices.

Cardiac Troponin Assays

Cardiac troponin assays are widely used to assist in the diagnosis of acute myocardial infarction and play a critical role in emergency medicine.

Following CE marking, manufacturers may use PMPF to monitor whether the assay continues to perform consistently across different laboratories and patient populations.

Typical PMPF activities may include:

Reviewing updated European Society of Cardiology (ESC) guidelines.
Monitoring published literature relating to cardiac biomarkers.
Analysing External Quality Assessment (EQA) results.
Reviewing laboratory quality control data.
Monitoring complaint trends relating to analytical performance.
Evaluating new evidence regarding diagnostic cut-off values.

The objective is to confirm that the assay continues to provide reliable diagnostic information and remains aligned with current clinical practice.

HbA1c Diagnostic Assays

HbA1c assays are routinely used for the diagnosis and long-term monitoring of diabetes mellitus.

Although the scientific validity of HbA1c is well established, manufacturers should continue monitoring post-market evidence to ensure ongoing performance.

Examples of PMPF activities include:

Reviewing updated diabetes management guidelines.
Monitoring proficiency testing schemes.
Evaluating laboratory performance trends.
Assessing customer feedback regarding assay performance.
Reviewing published evidence concerning new diagnostic thresholds.
Confirming consistency across different analyser platforms.

These activities help demonstrate that the assay continues to support accurate diagnosis and patient monitoring throughout its lifecycle.

Molecular Diagnostic Tests

Molecular diagnostics often target rapidly evolving infectious diseases or genetic conditions where scientific understanding changes quickly.

Consequently, PMPF programmes for molecular assays frequently require more extensive literature reviews and scientific monitoring.

Manufacturers may:

Review newly published molecular biology research.
Monitor emerging pathogen variants.
Evaluate updated clinical guidance.
Assess analytical performance using EQA programmes.
Monitor false-positive and false-negative trends.
Review performance within different patient populations.

Where significant scientific developments occur, manufacturers may need to update their Scientific Validity assessment, Performance Evaluation Report or intended purpose.

Companion Diagnostics

Companion diagnostics are used to determine whether patients are suitable for specific medicinal therapies and therefore require particularly robust PMPF programmes.

Manufacturers may monitor:

Updated oncology treatment guidelines.
Clinical trial publications.
Real-world treatment outcomes.
Biomarker prevalence studies.
Laboratory performance data.
Published evidence relating to new therapeutic indications.

As targeted therapies continue to evolve, PMPF helps ensure that the companion diagnostic remains clinically relevant and continues to support appropriate treatment decisions.

Blood Screening Assays

Blood donor screening assays are among the highest-risk IVDs because inaccurate results may have significant public health consequences.

Manufacturers typically operate extensive PMPF programmes that include:

National blood service performance data.
External Quality Assessment participation.
Epidemiological surveillance.
Vigilance reports.
Scientific literature reviews.
Emerging infectious disease monitoring.
Performance trend analysis.

This ongoing surveillance helps confirm that screening assays continue to provide reliable protection for both blood donors and recipients.

Artificial Intelligence and Software-Based IVDs

Artificial intelligence (AI) and software-based IVDs present unique PMPF challenges because algorithms, datasets and clinical practice may evolve over time.

Manufacturers may monitor:

Software performance metrics.
Algorithm accuracy.
False-positive and false-negative rates.
User feedback.
Clinical workflow integration.
Cybersecurity issues affecting performance.
Software updates.
Published AI validation studies.

For AI-enabled IVDs, PMPF often becomes one of the most important mechanisms for demonstrating that software continues to perform safely and effectively following deployment.

What These Examples Demonstrate

Although the specific PMPF activities vary between different types of IVDs, several common themes emerge.

Effective PMPF programmes consistently:

Collect evidence from multiple independent sources.
Monitor scientific developments.
Review real-world performance trends.
Confirm that Scientific Validity remains current.
Support updates to the Performance Evaluation Report.
Identify opportunities for continual improvement.
Maintain alignment with the current state of the art.

Rather than adopting a standardised approach for every product, manufacturers should design PMPF programmes that reflect the intended purpose, clinical significance and risk profile of each individual device.

By taking a proportionate, evidence-based approach, manufacturers can ensure that PMPF continues to provide meaningful information throughout the lifecycle of the device while supporting ongoing compliance with Regulation (EU) 2017/746.

Conclusion

Post-Market Performance Follow-up (PMPF) is a fundamental component of the IVDR lifecycle and ensures that manufacturers continue to demonstrate the safety, performance and scientific validity of their in vitro diagnostic medical devices long after CE marking has been achieved. Rather than viewing regulatory compliance as a one-time milestone, the IVDR requires manufacturers to continually collect, evaluate and act upon real-world evidence throughout the commercial life of their devices.

An effective PMPF programme enables manufacturers to confirm that Scientific Validity remains current, analytical performance continues to meet specifications and clinical performance continues to support meaningful clinical decision-making. By integrating PMPF with Post-Market Surveillance, risk management, Performance Evaluation and the Quality Management System, manufacturers can maintain technical documentation that reflects the latest scientific evidence and current state of the art.

Beyond regulatory compliance, PMPF provides valuable opportunities for continual improvement. Information gathered from scientific literature, laboratory performance data, customer feedback and clinical practice can help identify emerging risks, refine product performance and strengthen future device development. This proactive approach not only supports successful Notified Body surveillance but also reinforces confidence among healthcare professionals and patients that the device continues to perform safely and effectively.

Whether you are preparing your first PMPF Plan, updating an existing PMPF Report or developing a complete IVDR Performance Evaluation strategy, adopting a structured and evidence-based approach to Post-Market Performance Follow-up will help ensure ongoing compliance with Regulation (EU) 2017/746 and support the long-term success of your IVD throughout its lifecycle.

Frequently Asked Questions About PMPF

What is PMPF under the IVDR?

Post-Market Performance Follow-up (PMPF) is the continuous process of collecting and evaluating post-market evidence to confirm that an in vitro diagnostic medical device (IVD) continues to achieve its intended purpose after CE marking. PMPF forms part of the Performance Evaluation required under Regulation (EU) 2017/746 and helps ensure that Scientific Validity, analytical performance and clinical performance remain supported throughout the device lifecycle.

Is PMPF mandatory under the IVDR?

Yes. PMPF is a legal requirement under the IVDR where appropriate to the device and its risk profile. Manufacturers are expected to establish a PMPF programme that is proportionate to the intended purpose, classification and risks associated with the device. For many Class B, Class C and Class D IVDs, PMPF forms an essential part of ongoing regulatory compliance.

Which IVDR requirements cover PMPF?

The principal PMPF requirements are established within:

Article 56 – Performance Evaluation.
Annex XIII – Performance Evaluation, Performance Studies and Post-Market Performance Follow-up.
Annex I – General Safety and Performance Requirements (GSPRs).

Together, these provisions require manufacturers to continually review post-market evidence and update their Performance Evaluation where necessary.

What is the difference between PMPF and Post-Market Surveillance (PMS)?

Although closely related, PMPF and PMS have different objectives.

Post-Market Surveillance (PMS) monitors the overall safety, quality and performance of a device after it has been placed on the market.

Post-Market Performance Follow-up (PMPF) specifically focuses on confirming that the device continues to achieve its intended purpose by evaluating ongoing Scientific Validity, analytical performance and clinical performance.

PMPF therefore forms one important component of the wider PMS system.

What is the difference between PMPF and Vigilance?

Vigilance concerns the reporting and investigation of serious incidents and Field Safety Corrective Actions (FSCAs).

PMPF is a proactive process that continually collects and analyses post-market evidence to confirm continued device performance.

While Vigilance is event-driven, PMPF is an ongoing lifecycle activity that supports continual Performance Evaluation.

Does every IVD require a PMPF Plan?

Manufacturers should determine the scope of their PMPF activities based on the intended purpose, risk classification and characteristics of the device.

Higher-risk devices generally require more comprehensive PMPF programmes, while well-established lower-risk devices may justify more limited activities.

The manufacturer should be able to demonstrate that the chosen PMPF approach is appropriate and proportionate to the device.

What should a PMPF Plan include?

Although there is no mandatory IVDR template, a typical PMPF Plan includes:

Programme objectives.
Data sources.
Evidence collection methods.
Review frequencies.
Responsibilities.
Evaluation criteria.
Reporting procedures.
Links to the Performance Evaluation Report (PER).
Procedures for updating technical documentation.

The plan should describe how post-market evidence will be collected and evaluated throughout the device lifecycle.

What is a PMPF Report?

A PMPF Report documents the activities carried out under the PMPF Plan and summarises the conclusions drawn from the evidence collected.

It typically includes:

PMPF activities completed.
Scientific literature reviewed.
Complaint and trend analysis.
Performance data.
Risk evaluation.
Overall conclusions.
Recommendations for updates to the Performance Evaluation or technical documentation.

The report demonstrates that manufacturers are actively monitoring device performance after CE marking.

What types of evidence are used during PMPF?

Manufacturers may collect evidence from a variety of sources, including:

Scientific literature.
External Quality Assessment (EQA) programmes.
Proficiency testing.
Laboratory performance data.
Customer complaints.
User feedback.
Clinical registries.
Published clinical studies.
Vigilance investigations.
Trend analysis.
Distributor and service reports.

The evidence collected should be proportionate to the intended purpose and risk profile of the device.

How often should PMPF be performed?

PMPF is a continuous process rather than a one-time activity.

Manufacturers should review post-market evidence regularly throughout the commercial life of the device.

Additional reviews may be required following:

The review frequency should be justified within the PMPF Plan.

Does PMPF update the Performance Evaluation Report (PER)?

Yes.

One of the primary purposes of PMPF is to determine whether the conclusions within the Performance Evaluation Report remain valid.

Where significant new evidence becomes available, manufacturers should assess whether updates are required to:

What do Notified Bodies expect to see during PMPF reviews?

During conformity assessment and surveillance audits, Notified Bodies typically expect manufacturers to demonstrate:

A documented PMPF Plan.
Evidence that the plan has been implemented.
Systematic collection of post-market evidence.
Critical evaluation of performance data.
Updated scientific literature reviews.
Appropriate regulatory decisions.
Traceability between PMPF and the wider technical documentation.

A well-managed PMPF programme demonstrates that the manufacturer continues to monitor device performance after CE marking.

How does PMPF support ISO 13485?

PMPF integrates closely with an ISO 13485 Quality Management System by supporting:

Embedding PMPF within the Quality Management System helps ensure that post-market evidence is reviewed consistently and that appropriate actions are implemented when necessary.

What are the most common PMPF mistakes?

Common deficiencies include:

Treating PMPF as a one-time activity.
Confusing PMPF with PMS.
Relying only on complaint data.
Failing to review new scientific literature.
Poor traceability between regulatory documents.
Failing to document regulatory decisions.
Not updating the Performance Evaluation Report.
Applying identical PMPF programmes to every device.

A structured, risk-based and evidence-driven approach can help manufacturers avoid these common issues.

Can Patient Guard help with IVDR PMPF?

Yes.

Patient Guard supports manufacturers throughout the entire IVDR post-market lifecycle, including the preparation of PMPF Plans, PMPF Reports, Performance Evaluation Reports (PERs), Scientific Validity assessments, technical documentation and ISO 13485 Quality Management Systems.

Our regulatory consultants work with manufacturers of Class A, B, C and D IVDs to develop practical, proportionate and evidence-based PMPF programmes that support continued compliance with Regulation (EU) 2017/746 and successful Notified Body assessments.

References

This guide is based on the following European legislation, international standards and official regulatory guidance relating to IVDR Post-Market Performance Follow-up (PMPF), Performance Evaluation, post-market surveillance, risk management and the ongoing generation of clinical evidence for in vitro diagnostic medical devices.

Organisation	Reference	Why it's relevant
European Union	Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)	Provides the legal framework for IVDs placed on the European Union market. Article 56 and Annex XIII establish the requirements for Performance Evaluation and Post-Market Performance Follow-up, including the continuous updating of performance evidence throughout the device lifecycle.
European Union	IVDR Annex XIII – Performance Evaluation, Performance Studies and Post-Market Performance Follow-up	Sets out the detailed requirements for Performance Evaluation and PMPF. It describes PMPF as a continuous process for proactively collecting and evaluating performance and scientific data after a device has been placed on the market and establishes expectations for the PMPF Plan and documentation of PMPF findings.
European Union	IVDR Articles 78–81 – Post-Market Surveillance	Establish the wider post-market surveillance framework within which PMPF operates, including the PMS system, PMS Plan, PMS Report and Periodic Safety Update Report (PSUR). PMPF findings should feed into the manufacturer's wider post-market activities where relevant.
Medical Device Coordination Group (MDCG)	MDCG 2022-2 – Guidance on General Principles of Clinical Evidence for In Vitro Diagnostic Medical Devices	Provides detailed guidance on clinical evidence and Performance Evaluation under the IVDR. It explains the relationship between scientific validity, analytical performance and clinical performance and the importance of continuously updating the Performance Evaluation using post-market information, including PMPF.
Medical Device Coordination Group (MDCG)	MDCG 2025-5 – Questions and Answers Regarding Performance Studies of In Vitro Diagnostic Medical Devices Under Regulation (EU) 2017/746	Clarifies regulatory requirements applying to IVD performance studies. It is relevant where a manufacturer's PMPF strategy identifies the need to generate additional analytical or clinical performance evidence through post-market performance studies.
International Organization for Standardization (ISO)	ISO 20916:2019 – In Vitro Diagnostic Medical Devices – Clinical Performance Studies Using Specimens from Human Subjects – Good Study Practice	Defines good study practice for clinical performance studies involving specimens from human subjects. It may be applicable where PMPF activities include clinical performance studies designed to generate additional post-market clinical performance evidence.
International Organization for Standardization (ISO)	ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices	Provides the internationally recognised framework for medical device risk management. Findings generated through PMPF may identify new hazards, change existing risk estimates, influence risk controls or require reassessment of the overall benefit-risk determination.
International Organization for Standardization (ISO)	ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes	Defines Quality Management System requirements supporting controlled PMPF activities, including document control, complaint handling, CAPA, competence, change management, management review and the maintenance of regulatory documentation throughout the device lifecycle.
Medical Device Coordination Group (MDCG)	MDCG-Endorsed Documents and Other Medical Device Guidance	Provides the European Commission's central index of MDCG guidance supporting implementation of the IVDR. Manufacturers should review this resource periodically for new or updated guidance relevant to Performance Evaluation, PMPF, PMS, vigilance and clinical evidence.

Post-Market Performance Follow-up is a continuous lifecycle activity rather than a one-time regulatory exercise. Manufacturers should consult the latest consolidated version of Regulation (EU) 2017/746, applicable international standards and current MDCG guidance when establishing and maintaining their PMPF programme, preparing PMPF Plans and Reports and updating the Performance Evaluation throughout the device lifecycle.

David Small BSc (Hons), MSc, MTOPRA

Reviewed by
David Small, BSc (Hons), MSc, MTOPRA
Founder & CEO |
20+ years in medical device regulatory affairs, MDR/IVDR compliance and quality systems.

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