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Post-Market Surveillance (PMS) for Medical Devices and IVDs

A comprehensive guide to post-market surveillance under the EU MDR, EU IVDR and UK MDR. Understand PMS plans, PMS reports, PSURs, vigilance, PMCF, PMPF and how manufacturers must monitor the safety and performance of medical devices and IVDs throughout their lifecycle.

Updated: 28th June 2026

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

Post-Market Surveillance for Medical Devices and IVDs

Post-market surveillance (PMS) is the systematic process of monitoring the safety, performance and continued suitability of a medical device or in vitro diagnostic (IVD) after it has been placed on the market.

For manufacturers, PMS is not simply a regulatory reporting exercise. It is a continuous process that uses real-world information to identify emerging risks, detect trends, confirm that a device continues to perform as intended and determine whether corrective or preventive action is required.

Under the EU Medical Device Regulation (MDR) 2017/745 and EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, manufacturers must establish, document, implement, maintain and update a post-market surveillance system proportionate to the risk class and appropriate for the type of device.

Information gathered through PMS feeds back into key areas of the manufacturer’s regulatory and quality system, including:

Risk management
Clinical evaluation for medical devices
Performance evaluation for IVDs
Post-Market Clinical Follow-up (PMCF)
Post-Market Performance Follow-up (PMPF)
Complaint handling and vigilance
Periodic Safety Update Reports (PSURs)
Post-Market Surveillance Reports
Corrective and preventive actions (CAPA)
Technical documentation

In Great Britain, manufacturers must also consider the post-market surveillance requirements of the UK Medical Devices Regulations 2002 (UK MDR), including the strengthened PMS requirements that came into force on 16 June 2025.

This guide explains how post-market surveillance works across the EU MDR, EU IVDR and UK MDR, what manufacturers are expected to collect and evaluate, which reports are required for different device classifications, and how PMS connects with risk management, clinical or performance evaluation, vigilance and continuous improvement.

Post-Market Surveillance Requirements: EU MDR vs EU IVDR

The EU MDR and EU IVDR follow a similar framework for post-market surveillance, but there are important differences in terminology, device classification and the reports manufacturers must prepare.

Both Regulations require manufacturers to establish a PMS system that is proportionate to the risk class and appropriate for the type of device. The system must actively and systematically collect and analyse information on the quality, safety and performance of the device throughout its lifetime.

The table below provides a quick comparison of the principal PMS requirements.

PMS Requirement	EU MDR 2017/745	EU IVDR 2017/746
PMS System	Article 83	Article 78
PMS Plan	Article 84	Article 79
PMS Report	Class I – Article 85	Classes A and B – Article 80
PSUR	Classes IIa, IIb and III – Article 86	Classes C and D – Article 81
Post-Market Follow-up	PMCF	PMPF
Clinical / Performance Evidence	Clinical Evaluation	Performance Evaluation
Risk Management Feedback	Required	Required
Trend Reporting	Article 88	Article 83
Serious Incidents & FSCA	Article 87	Article 82

Which PMS Report Does Your Device Require?

Under the EU MDR:

Class I devices require a Post-Market Surveillance Report under Article 85. The report must be updated when necessary.
Class IIa devices require a Periodic Safety Update Report (PSUR) under Article 86, updated when necessary and at least every two years.
Class IIb and Class III devices require a PSUR under Article 86, updated at least annually.

Under the EU IVDR:

Class A and Class B IVDs require a Post-Market Surveillance Report under Article 80, updated when necessary.
Class C and Class D IVDs require a Periodic Safety Update Report (PSUR) under Article 81, updated at least annually.

The PMS Report or PSUR is therefore not a standalone regulatory document. It is the documented output of a wider surveillance system in which information is continuously collected, evaluated and fed back into the manufacturer’s technical documentation, risk management and quality management system.

For medical devices under the MDR, PMS information also feeds into the Clinical Evaluation and, where applicable, Post-Market Clinical Follow-up (PMCF).

For IVDs under the IVDR, PMS information feeds into the Performance Evaluation and Post-Market Performance Follow-up (PMPF).

This creates a continuous lifecycle process in which real-world experience is used to confirm that the device remains safe, performs as intended and continues to have an acceptable benefit-risk profile after being placed on the market.

What Is Post-Market Surveillance (PMS)?

Post-market surveillance (PMS) is the ongoing process used by manufacturers to actively and systematically collect, analyse and evaluate information about a medical device or IVD after it has been placed on the market.

The purpose of PMS is to ensure that manufacturers continue to understand how their devices perform when used in real-world conditions. Pre-market testing, clinical investigations and performance studies provide essential evidence before market access, but they cannot always identify every issue that may arise once a device is used across larger populations, different healthcare settings and over longer periods of time.

An effective PMS system therefore enables manufacturers to identify new or changing risks, detect trends and confirm whether the safety and performance demonstrated before market access continue to remain acceptable.

PMS Is a Continuous Lifecycle Process

Post-market surveillance should not be treated as a report that is prepared periodically and then filed away. It is a continuous process that connects information from the market back into the manufacturer’s quality management system and technical documentation.

Information collected through PMS may include:

Complaints and customer feedback
Serious and non-serious incidents
Adverse events and undesirable side effects
Product returns and warranty information
Device malfunctions and failures
Trend data
Scientific and technical literature
Information concerning similar devices or IVDs
Feedback from distributors, importers and healthcare professionals
Data from Post-Market Clinical Follow-up (PMCF)
Data from Post-Market Performance Follow-up (PMPF)
Field Safety Corrective Actions (FSCAs)
Information from registries or other real-world data sources, where applicable

This information must then be evaluated to determine whether action is necessary.

For example, PMS data may identify the need to:

Update the risk management file
Revise the Clinical Evaluation for a medical device
Update the Performance Evaluation for an IVD
Modify the Instructions for Use (IFU) or labelling
Update the device’s benefit-risk determination
Introduce corrective or preventive actions
Improve the design or manufacturing process
Conduct additional PMCF or PMPF activities
Initiate a Field Safety Corrective Action
Submit a vigilance or trend report to the relevant Competent Authority

From Reactive Monitoring to Proactive Surveillance

An important principle of modern post-market surveillance is that manufacturers should not rely solely on complaints and incidents.

Complaint handling is an important source of PMS information, but an effective PMS system should actively seek information capable of identifying emerging safety or performance issues before they develop into more significant problems.

Manufacturers should therefore define appropriate methods for collecting both reactive and proactive post-market data based on the type of device, its intended purpose, risk classification, expected lifetime and known or foreseeable risks.

The overall objective is to create a continuous feedback loop:

Market Data → Analysis → Risk & Evidence Review → Corrective Action → Continued Monitoring

For medical devices, this feedback contributes to ongoing Clinical Evaluation and PMCF activities. For IVDs, it contributes to ongoing Performance Evaluation and PMPF activities.

When implemented effectively, PMS provides manufacturers with the evidence needed to demonstrate that their medical devices and IVDs continue to be safe, perform as intended and maintain an acceptable benefit-risk profile throughout their lifecycle.

Why Is Post-Market Surveillance Important?

Post-market surveillance plays a critical role in ensuring that medical devices and IVDs continue to be safe and perform as intended throughout their lifecycle.

Even a well-designed device supported by comprehensive pre-market testing cannot be evaluated under every possible real-world condition before it reaches the market. Once a device is used across larger patient populations, different healthcare environments and over longer periods, new information may emerge that was not identified during development or conformity assessment.

PMS provides the mechanism for identifying, evaluating and responding to this information.

Protecting Patients and Users

The primary objective of PMS is to protect patients, users and other persons from unacceptable risks.

By continuously reviewing information from complaints, incidents, product performance, scientific literature and other post-market sources, manufacturers can identify potential safety signals and take appropriate action before an issue becomes more widespread.

Identifying Emerging Risks and Trends

Individual complaints or incidents may appear insignificant when considered in isolation. When data is collected and analysed systematically, however, patterns may become visible.

PMS can help manufacturers identify:

Increasing complaint or failure rates
Previously unidentified hazards
Changes in the frequency or severity of known risks
Unexpected adverse events or undesirable side effects
Deterioration in device performance
Use-related problems
Issues affecting particular patient or user populations
Changes in the state of the art

Early identification of these signals allows manufacturers to investigate their significance and determine whether corrective action is required.

Confirming Continued Safety and Performance

Obtaining CE marking does not end the manufacturer’s responsibility for demonstrating device safety and performance.

Post-market data should continually support the conclusions made within the technical documentation.

For medical devices, PMS provides important input into the Clinical Evaluation and helps determine whether clinical evidence continues to support the device’s intended purpose, safety, clinical performance and benefit-risk profile.

For IVDs, PMS contributes to the ongoing Performance Evaluation and helps confirm continued scientific validity, analytical performance and clinical performance, as applicable.

Maintaining an Acceptable Benefit-Risk Profile

PMS and risk management are closely connected.

Information collected after market introduction may confirm existing risk estimates or reveal that the probability or severity of a risk differs from what was originally anticipated.

Manufacturers must therefore use relevant PMS information to keep their risk management documentation and benefit-risk determination up to date.

Where new or increased risks are identified, additional risk control measures may be necessary.

Driving Corrective Action and Product Improvement

PMS should lead to action where the data indicates that improvement is necessary.

Depending on the findings, this could include:

Corrective and preventive action (CAPA)
Changes to device design or manufacturing
Updates to labelling or Instructions for Use
Additional user training
Changes to risk control measures
Additional PMCF or PMPF activities
Updates to Clinical or Performance Evaluation
Field Safety Corrective Actions (FSCAs)

PMS therefore supports not only regulatory compliance but also the continuous improvement of the device and the manufacturer’s quality management system.

Supporting Continued Regulatory Compliance

Post-market surveillance is a legal obligation under both the EU MDR and EU IVDR and forms an essential part of lifecycle regulatory compliance.

Manufacturers must be able to demonstrate that appropriate PMS processes are established, that relevant data is being collected and analysed, and that the results are being used to maintain required documentation such as PMS Reports, PSURs, risk management documentation and clinical or performance evaluation.

A weak PMS system can therefore affect far more than a single report. It can expose deficiencies across technical documentation, risk management, vigilance, clinical or performance evidence and the manufacturer’s quality management system.

Effective PMS provides the ongoing evidence manufacturers need to demonstrate that their medical devices and IVDs remain safe, effective or perform as intended, and compliant throughout their time on the market.

Building a Post-Market Surveillance System Under the MDR and IVDR

Every manufacturer must establish a post-market surveillance system as an integral part of its quality management system.

The core requirements are established under Article 83 of the EU MDR and Article 78 of the EU IVDR. Both Regulations require the PMS system to be proportionate to the risk class and appropriate for the type of device.

The system must be designed to actively and systematically gather, record and analyse relevant data on the quality, performance and safety of a device throughout its entire lifetime.

This means manufacturers need more than a procedure for handling complaints. They need a structured system that defines what information will be collected, where it will come from, how frequently it will be reviewed, who is responsible for analysing it and what happens when a potential safety or performance issue is identified.

What Should a PMS System Include?

The exact structure will depend on the device and organisation, but an effective PMS system should establish processes for:

Collecting post-market information from appropriate internal and external sources
Reviewing complaints, incidents, product returns and customer feedback
Monitoring safety and performance trends
Reviewing relevant scientific and technical literature
Evaluating information concerning similar devices or IVDs
Conducting PMCF activities for medical devices, where applicable
Conducting PMPF activities for IVDs, where applicable
Identifying potential safety signals and emerging risks
Assessing whether incidents meet vigilance reporting requirements
Determining whether trend reporting is required
Escalating significant safety or performance issues
Initiating CAPA where necessary
Implementing Field Safety Corrective Actions (FSCAs), where required
Updating risk management and benefit-risk conclusions
Updating Clinical Evaluation or Performance Evaluation
Preparing and maintaining PMS Reports or PSURs

The PMS system should ensure that information does not remain isolated within individual departments. Complaint data, vigilance information, risk management, clinical or performance evidence and CAPA findings should form part of a connected lifecycle process.

PMS Must Be Proportionate to the Device

The MDR and IVDR require the PMS system to be proportionate to the risk class and appropriate for the type of device.

There is therefore no single PMS approach that is appropriate for every product.

The surveillance strategy for a low-risk, well-established device may be very different from that required for a high-risk implantable device or a Class D IVD.

When designing the PMS system, manufacturers should consider factors such as:

Device or IVD classification
Intended purpose
Target patient or user population
Device complexity
Novelty of the technology
Known and foreseeable risks
Severity of potential harm
Expected device lifetime
Frequency and conditions of use
Availability of long-term safety or performance data
Uncertainties or limitations in the existing clinical or performance evidence
Previous complaints, incidents and safety signals

Higher-risk or novel devices will generally require more extensive and proactive surveillance than mature, lower-risk products with a well-established safety and performance profile.

PMS Responsibilities Should Be Clearly Defined

Manufacturers should clearly define who is responsible for collecting, reviewing, analysing and escalating post-market information.

Depending on the size of the organisation, PMS activities may involve personnel from:

Regulatory Affairs
Quality Assurance
Clinical Affairs
Medical or Scientific Affairs
Customer Service
Technical Support
Engineering
Manufacturing
Sales and distribution

Responsibilities, escalation routes and reporting timelines should be documented within the manufacturer’s quality management system.

Relevant information received by distributors, importers and other economic operators should also be communicated to the manufacturer through established processes.

The PMS System Must Produce Actionable Information

Collecting data alone does not constitute effective post-market surveillance.

Manufacturers must analyse the information collected and determine what it means for the continued safety, performance and regulatory compliance of the device.

The outputs of the PMS system should enable the manufacturer to:

Update the benefit-risk determination
Improve risk management
Update design and manufacturing information
Update the Instructions for Use and labelling where necessary
Update Clinical Evaluation or Performance Evaluation
Identify requirements for preventive, corrective or field safety corrective action
Identify opportunities to improve the usability, performance and safety of the device
Detect and report trends where required
Contribute relevant information to the surveillance of other devices where appropriate

The results of these activities ultimately feed into formal PMS documentation, including the PMS Report or Periodic Safety Update Report (PSUR), depending on the classification of the medical device or IVD.

PMS Should Operate as a Feedback Loop

An effective PMS system creates a continuous feedback loop between real-world device experience and the manufacturer’s regulatory and quality processes:

Post-Market Data → Analysis → Signal Detection → Risk & Evidence Review → Action → Documentation Update → Continued Monitoring

The objective is not simply to demonstrate that PMS activities have been performed. Manufacturers should be able to show that post-market information is being actively evaluated and, where necessary, translated into meaningful action.

This lifecycle approach helps ensure that medical devices and IVDs continue to meet applicable safety and performance requirements for as long as they remain on the market.

The Post-Market Surveillance Plan (PMS Plan)

The Post-Market Surveillance Plan, commonly referred to as the PMS Plan, defines how a manufacturer will proactively collect, analyse and evaluate information about a medical device or IVD once it has been placed on the market.

Under the EU MDR, the PMS Plan is required by Article 84, with detailed requirements set out in Annex III. Under the EU IVDR, the equivalent requirement is established by Article 79 and Annex III.

The PMS Plan should not simply describe which post-market activities the manufacturer intends to perform. It should establish a systematic and documented approach for obtaining meaningful information about the continued quality, safety and performance of the device.

What Should a PMS Plan Include?

Annex III of both the MDR and IVDR establishes the information and processes that manufacturers should address within their PMS Plan.

The plan should consider appropriate sources of post-market information, including:

Serious incidents and Field Safety Corrective Actions (FSCAs)
Non-serious incidents
Undesirable side effects, where applicable
Trend reporting information
Complaints and customer feedback
Feedback from users, distributors and importers
Relevant scientific and technical literature
Relevant databases and registers
Publicly available information concerning similar devices
Data generated through PMCF for medical devices
Data generated through PMPF for IVDs

The manufacturer should determine which sources are relevant to the particular device and establish how information from those sources will be collected and reviewed.

Proactive and Reactive PMS Data

A robust PMS Plan should include both reactive and proactive methods of surveillance.

Reactive PMS activities respond to information received after an event or issue has occurred. Examples may include:

Customer complaints
Reported incidents
Product returns
Warranty claims
Technical support enquiries
Device malfunctions
Distributor or importer feedback

Proactive PMS activities actively seek information about the safety and performance of the device rather than waiting for an issue to be reported.

Depending on the device, these may include:

PMCF or PMPF activities
User or customer surveys
Follow-up questionnaires
Literature surveillance
Registry data
Real-world evidence
Structured user feedback
Review of publicly available information concerning similar devices
Analysis of sales, usage and exposure data

The balance between proactive and reactive activities should reflect the risk classification, intended purpose, technology, clinical or performance evidence, known risks and uncertainties associated with the device.

Methods for Assessing PMS Data

The PMS Plan should also define how the information collected will be evaluated.

Simply collecting complaints or other post-market information is not sufficient. Manufacturers need appropriate methods for determining whether the data indicates a change in the safety, performance or benefit-risk profile of the device.

The plan should therefore define, where appropriate:

Methods for analysing complaints and market experience
Methods for identifying signals and emerging risks
Statistical methods used for trend analysis
Indicators and threshold values
Methods for reassessing the benefit-risk determination
Methods for reviewing the effectiveness of existing risk controls
Processes for escalating potential safety or performance issues
Criteria for initiating CAPA
Criteria for considering vigilance or trend reporting
Methods for determining whether additional PMCF or PMPF is required

Thresholds should be meaningful for the particular device rather than being selected simply to satisfy a procedural requirement.

For example, a manufacturer may establish thresholds relating to complaint rates, failure rates, specific adverse events or other performance indicators. Exceeding a predefined threshold may trigger further investigation, risk assessment or corrective action.

PMS Plan and Risk Management

The PMS Plan should be closely linked to the manufacturer’s risk management process.

Known and foreseeable risks identified through risk management can help determine what the PMS system should monitor. In return, information obtained through PMS provides real-world evidence that can confirm or challenge assumptions made within the risk management file.

For example, PMS data may demonstrate that:

A hazardous situation occurs more frequently than originally estimated
The severity of harm differs from the original assessment
A previously unidentified hazard has emerged
An existing risk control is less effective than expected
New information affects the overall benefit-risk determination

Where relevant information is identified, the risk management documentation should be reviewed and updated accordingly.

PMS Plan and PMCF for Medical Devices

For medical devices subject to the MDR, Post-Market Clinical Follow-up (PMCF) forms part of the wider post-market surveillance framework.

The PMS Plan should therefore be aligned with the manufacturer’s PMCF activities.

PMCF may be used to proactively collect clinical data to confirm continued device safety and performance, identify previously unknown side effects, monitor identified risks and investigate potential emerging risks.

The results of PMCF activities should feed back into the Clinical Evaluation, risk management and relevant PMS documentation.

PMS Plan and PMPF for IVDs

For IVDs, the equivalent post-market activity is Post-Market Performance Follow-up (PMPF).

PMPF is used to proactively collect and evaluate performance and scientific data relating to the use of an IVD after it has been placed on the market.

PMPF findings can help confirm continued safety and performance, identify new risks or limitations and determine whether the conclusions within the Performance Evaluation remain valid.

The PMS Plan, PMPF activities, Performance Evaluation and risk management process should therefore operate as interconnected elements of the IVD lifecycle.

The PMS Plan Should Be Device-Specific

One of the most important principles when developing a PMS Plan is that it should reflect the actual device.

A generic PMS template containing standard activities without considering the characteristics and risks of the product is unlikely to provide an effective surveillance strategy.

Manufacturers should consider factors such as:

Device classification
Intended purpose
Target population
Technology and operating principle
Expected lifetime
Frequency of use
Known risks and residual risks
Clinical or performance evidence
Novelty of the device
Previous post-market experience
Similar devices already available on the market
Uncertainties identified during Clinical Evaluation or Performance Evaluation

The resulting plan should make clear what information will be collected, how it will be evaluated, how frequently activities will be performed and what actions may be triggered by the findings.

A well-designed PMS Plan provides the foundation for the manufacturer’s entire post-market surveillance system and ultimately determines the quality of the information available for PMS Reports, PSURs, risk management, Clinical Evaluation and Performance Evaluation.

Post-Market Surveillance Data: What Should Manufacturers Collect?

The effectiveness of a post-market surveillance system depends heavily on the quality and relevance of the information collected.

Under both the EU MDR and EU IVDR, manufacturers are expected to actively and systematically gather information relating to the quality, safety and performance of their devices throughout their lifetime. Annex III of both Regulations identifies a range of information sources that should be considered within the PMS system.

The exact combination of data sources should be appropriate for the device, its intended purpose, risk classification and post-market surveillance objectives.

Complaints and Customer Feedback

Complaints are one of the most important sources of real-world information available to manufacturers.

Complaint data may reveal:

Device malfunctions or failures
Performance problems
Use errors or usability issues
Packaging or labelling problems
Unexpected adverse events
Recurring product defects
Issues affecting particular users or patient groups

Manufacturers should not review complaints only as individual cases. Aggregated complaint data should also be analysed to identify patterns, changes in frequency and potential emerging safety or performance signals.

Serious and Non-Serious Incidents

Information concerning serious incidents must form part of the PMS system, but non-serious incidents are also important.

A series of apparently minor events may indicate a developing problem even when individual cases do not meet the criteria for serious incident reporting.

Manufacturers should therefore maintain processes capable of identifying changes in both the frequency and severity of incidents.

Where applicable, PMS data should also include information associated with Field Safety Corrective Actions (FSCAs) and previous vigilance activities.

Product Returns, Failures and Service Data

Returned products can provide valuable information about how devices perform in real-world conditions.

Depending on the type of device, manufacturers may evaluate:

Reasons for product return
Confirmed device failures
No-fault-found investigations
Repair and servicing records
Component failures
Software errors
Calibration problems
Warranty claims
Technical support enquiries

These data can help identify recurring failure modes that may not be apparent from complaints alone.

Feedback from Users, Distributors and Importers

The MDR and IVDR specifically recognise information received from users, distributors and importers as a source of PMS data.

Manufacturers should establish mechanisms that allow relevant information to flow back through the supply chain.

Feedback may include observations concerning:

Device performance
Customer complaints
Product handling
Storage and transportation
Labelling and Instructions for Use
User difficulties
Product failures
Safety concerns
Changes in customer or clinical practice

Distributors and importers can therefore play an important role in identifying post-market information that might otherwise never reach the manufacturer.

Scientific and Technical Literature

Relevant scientific and technical literature should be monitored as part of the PMS system.

Literature surveillance can help identify:

New safety information
Emerging risks
Changes in clinical practice
New information about the technology
Changes in the state of the art
Performance limitations
New treatment or diagnostic alternatives
Information concerning similar or comparable devices

Literature review should be appropriately targeted and documented so that manufacturers can demonstrate how relevant findings have been evaluated.

Databases and Registries

Relevant databases, registers and registries may provide valuable real-world information, particularly for devices used across large patient populations or over extended periods.

Depending on the product, these sources may provide information concerning:

Adverse events
Device failures
Long-term outcomes
Revision or replacement rates
Diagnostic performance
Patient outcomes
Device utilisation

Not every device will have access to a relevant registry or external database. Where appropriate sources exist, however, manufacturers should consider whether they can contribute meaningful information to the PMS process.

Information About Similar Devices and IVDs

PMS should not necessarily be limited to information generated by the manufacturer’s own product.

Annex III of both the MDR and IVDR includes publicly available information concerning similar devices as a relevant source of post-market information.

Monitoring similar products may help identify:

Technology-related risks
Emerging safety concerns
Known failure modes
Regulatory safety actions
Changes in the state of the art
New clinical or performance information

Information identified for another device does not automatically mean that the same issue applies to the manufacturer’s product. However, potentially relevant findings should be assessed to determine whether they affect the manufacturer’s risk management, clinical or performance evidence, or PMS strategy.

PMCF and PMPF Data

Proactive post-market follow-up activities can provide particularly valuable evidence.

For medical devices under the MDR, Post-Market Clinical Follow-up (PMCF) can generate clinical data concerning continued safety, clinical performance and benefit-risk.

For IVDs under the IVDR, Post-Market Performance Follow-up (PMPF) can provide information concerning continued scientific validity, analytical performance and clinical performance, as applicable.

These activities may be particularly important where uncertainties remain following pre-market evaluation or where additional long-term or real-world evidence is necessary.

Sales, Distribution and Exposure Data

PMS data should be interpreted in the context of how widely the device is actually being used.

A manufacturer that receives 20 complaints from 1,000 devices distributed has a very different potential signal from a manufacturer receiving 20 complaints from one million devices.

Depending on the device, useful denominator or exposure information may include:

Number of devices sold
Number of devices distributed
Number of tests performed
Number of procedures performed
Estimated number of patients exposed
Usage frequency
Geographic distribution
Time on the market

This information can support meaningful calculation of complaint, incident or failure rates and is particularly important when assessing trends.

PMS Data Should Be Analysed, Not Simply Collected

A large volume of post-market data has little regulatory value if the manufacturer does not analyse it effectively.

Manufacturers should establish methods that allow information from different sources to be brought together and evaluated for meaningful patterns.

For example:

Complaint Data + Incident Data + PMCF/PMPF + Literature + Market Exposure → PMS Analysis

The analysis should help determine whether:

New hazards have emerged
Known risks have changed
Complaint or incident rates are increasing
Device performance remains acceptable
Existing risk controls remain effective
The benefit-risk determination remains favourable
Additional investigation is required
CAPA should be initiated
Vigilance or trend reporting obligations have been triggered
Clinical Evaluation or Performance Evaluation requires updating

The objective is not to collect every piece of information available. It is to establish a proportionate surveillance system capable of generating reliable evidence about how the device is performing in the real world and identifying when action is necessary.

Complaint Handling and Post-Market Surveillance

Complaint handling is a fundamental part of post-market surveillance for both medical devices and IVDs.

Complaints provide manufacturers with direct information about how their products perform once they are placed on the market. They may identify device failures, performance problems, usability issues, adverse events or other concerns that were not apparent during pre-market evaluation.

However, complaint handling should not be confused with the entire PMS process. Complaints are one source of PMS data within a much broader surveillance system.

What Is a Medical Device or IVD Complaint?

A complaint may relate to an alleged deficiency concerning the identity, quality, durability, reliability, usability, safety or performance of a medical device or IVD after it has been released for distribution.

Examples may include:

Device malfunction or failure
Unexpected or incorrect results
Deterioration in performance
Packaging failure
Labelling errors
Problems with the Instructions for Use
Software errors
Usability problems
Missing or damaged components
Unexpected adverse events
Problems associated with device reliability
Customer concerns regarding safety or performance

Manufacturers should have documented procedures for receiving, recording, assessing, investigating and closing complaints.

Every Complaint Should Be Evaluated

Each complaint should undergo an appropriate initial assessment to determine its nature and potential significance.

This assessment should consider questions such as:

What happened?
Which device, model, batch, lot or software version was involved?
Was the device used according to its intended purpose?
Was there an actual or potential impact on a patient, user or other person?
Did the device malfunction or fail to perform as intended?
Has the same or a similar issue occurred previously?
Does the event require further investigation?
Could the complaint represent a reportable serious incident?
Could it contribute to a reportable trend?
Does it indicate a potential new or increased risk?

Where information is incomplete, manufacturers should make reasonable efforts to obtain sufficient information to support the assessment.

Complaint Investigation

Not every complaint will require the same level of investigation.

The extent of the investigation should be proportionate to the potential safety or performance implications of the issue.

An investigation may include:

Examination of the returned device
Review of manufacturing and batch records
Review of quality control or release records
Software or technical investigation
Root cause analysis
Review of similar complaints
Review of risk management documentation
Assessment of supplier or component issues
Review of device usage and user information
Evaluation of relevant clinical or performance information

Where a complaint is not investigated, the manufacturer should have an appropriate documented rationale for that decision.

Complaints and Vigilance Reporting

One of the most important stages of complaint handling is determining whether an event triggers regulatory vigilance obligations.

Manufacturers should assess complaints promptly to determine whether they involve a serious incident that must be reported to the relevant Competent Authority.

This assessment should not wait until the entire technical investigation has been completed if the information already available indicates that regulatory reporting requirements may apply.

A complaint may therefore lead to:

Complaint → Reportability Assessment → Vigilance Report → Investigation → Corrective Action

Where necessary, the investigation may also result in a Field Safety Corrective Action (FSCA).

Complaint Trending and Signal Detection

Manufacturers should not evaluate complaints only on a case-by-case basis.

Complaint information should also be aggregated and analysed over time to identify changes in frequency, severity or type.

For example, a single device failure may not indicate a significant safety issue. A sustained increase in the same failure mode across multiple devices may indicate an emerging signal requiring investigation.

Useful complaint metrics may include:

Overall complaint rate
Complaints by failure mode
Complaints by device or product family
Complaints by batch or lot
Complaints by geographic market
Complaints by severity
Complaints resulting in reportable incidents
Complaints resulting in CAPA
Complaints relative to units sold or estimated device usage

Using rates rather than raw complaint numbers can be particularly important where sales or device usage changes significantly over time.

Complaints and Trend Reporting

Under both the MDR and IVDR, manufacturers may be required to report statistically significant increases in the frequency or severity of certain incidents that are not serious incidents, or expected undesirable side effects that could have a significant impact on the benefit-risk analysis and could lead to unacceptable risks.

Manufacturers therefore need appropriate methods for identifying meaningful changes in post-market data.

Trend analysis should consider suitable observation periods, baseline rates, statistical methods and predefined indicators or threshold values appropriate to the device.

Complaints and CAPA

A complaint may also trigger the manufacturer’s Corrective and Preventive Action (CAPA) process.

CAPA may be appropriate where investigation identifies issues such as:

Recurring device failures
Systemic manufacturing problems
Design deficiencies
Inadequate risk controls
Supplier-related problems
Labelling or usability issues
Software defects
Recurring non-conformities

Where CAPA is initiated, manufacturers should determine the root cause, implement appropriate actions and verify or monitor whether those actions have been effective.

Feeding Complaint Data Back Into PMS and Risk Management

Complaint handling should ultimately feed information back into the wider PMS system.

Relevant findings may require updates to:

Risk management documentation
Clinical Evaluation
Performance Evaluation
PMCF or PMPF activities
PMS Plans
PMS Reports
PSURs
Instructions for Use or labelling
Design or manufacturing documentation
CAPA records

This feedback process is essential because a complaint may provide real-world evidence that an existing risk occurs more frequently than anticipated, that a risk control is not sufficiently effective or that a previously unidentified hazard exists.

Complaint → Investigation → Trending → Risk Assessment → CAPA/Vigilance → PMS Output

An effective complaint handling system therefore does more than resolve individual customer concerns. It transforms real-world feedback into structured information that can be used to detect emerging problems, maintain the device’s safety and performance and support continued regulatory compliance.

Trend Reporting and Signal Detection Under the MDR and IVDR

Trend analysis is an important part of post-market surveillance because it can identify developing safety or performance problems that may not be apparent when individual complaints or incidents are assessed separately.

Manufacturers should routinely analyse relevant PMS data to identify changes in the frequency, severity or nature of events associated with their medical devices and IVDs.

In certain circumstances, an identified trend may also trigger a formal regulatory reporting obligation.

Under the EU MDR, trend reporting is addressed by Article 88. Under the EU IVDR, the corresponding requirements are established by Article 83.

What Is Trend Reporting?

Trend reporting is intended to identify statistically significant increases in certain events that could affect the benefit-risk profile of a device.

For medical devices under the MDR, manufacturers must report statistically significant increases in the frequency or severity of incidents that are not serious incidents, or expected undesirable side effects, where they could have a significant impact on the benefit-risk analysis and have led or may lead to risks that are unacceptable when weighed against the intended benefits.

For IVDs under the IVDR, manufacturers must similarly consider statistically significant increases in the frequency or severity of incidents that are not serious incidents.

The IVDR also specifically addresses significant increases in expected erroneous results when compared with the stated performance of the IVD.

This distinction is particularly important for IVD manufacturers because deterioration in diagnostic performance may create significant patient risk even where the device itself does not directly cause physical harm.

Routine PMS Trending vs Regulatory Trend Reporting

Manufacturers should distinguish between routine trending and formal regulatory trend reporting.

Routine trending is part of the manufacturer’s normal PMS activities and may include monitoring:

Complaint rates
Device failure rates
Specific failure modes
Non-serious incidents
Expected undesirable side effects
False-positive or false-negative results for IVDs
Invalid or indeterminate IVD results
Product returns
Technical support enquiries
Software-related problems
Manufacturing or quality issues
PMCF or PMPF findings

A change in one of these indicators does not automatically mean that a regulatory trend report is required.

The manufacturer must evaluate whether the increase is statistically significant and whether the applicable regulatory criteria for trend reporting have been met.

Establishing Indicators and Threshold Values

Manufacturers should establish appropriate indicators and threshold values within their PMS system.

The PMS Plan should define the methods used to identify statistically significant increases and the observation period over which data will be assessed.

Depending on the device, manufacturers may establish indicators based on:

Complaints per number of devices sold
Incidents per number of devices in use
Failures per procedure
Events per patient exposure
Errors per number of tests performed
False-positive or false-negative rates
Specific device failure modes
Severity of reported events

The methodology should be appropriate for the device and capable of detecting meaningful changes in post-market performance.

Why Denominator Data Matters

Raw complaint or incident numbers can be misleading if they are not considered in the context of device exposure.

For example, an increase from 20 to 40 complaints may initially appear concerning. However, if the number of devices sold increased from 10,000 to 40,000 during the same period, the complaint rate has actually decreased.

Manufacturers should therefore use suitable denominator data wherever possible.

Depending on the product, this might include:

Units sold
Units distributed
Installed devices
Procedures performed
Tests performed
Estimated patient exposure
Device usage frequency

Using appropriate rates makes it easier to distinguish genuine deterioration in safety or performance from changes caused simply by increased market exposure.

Establishing an Observation Period

Trend analysis also requires an appropriate observation period.

A period that is too short may generate misleading signals from normal variation, while a period that is too long may delay identification of an emerging safety issue.

The appropriate period will depend on factors such as:

Device risk
Sales volume
Frequency of use
Expected event frequency
Device lifetime
Severity of potential harm
Availability of historical data
Speed at which a potential problem could affect patients or users

The methodology and observation period used for determining statistically significant increases should be defined within the PMS Plan.

Signal Detection

Trend analysis is closely related to signal detection.

A signal is information that may indicate a new or changing safety or performance issue requiring further evaluation.

Signals may emerge from:

Increasing complaint rates
Repeated device failures
Changes in incident severity
PMCF or PMPF findings
Scientific literature
Registry information
Regulatory safety notices
Information concerning similar devices
Customer or healthcare professional feedback

An identified signal should be investigated to determine whether it represents a genuine change in the device’s safety, performance or benefit-risk profile.

What Happens When a Trend Is Identified?

When a potentially significant trend is detected, the manufacturer should investigate its cause and assess its regulatory and safety implications.

This may include:

Reviewing individual complaints or incidents
Conducting statistical analysis
Reviewing manufacturing or batch information
Evaluating the risk management file
Reviewing Clinical Evaluation or Performance Evaluation
Assessing PMCF or PMPF data
Investigating potential root causes
Determining whether CAPA is required
Assessing whether the benefit-risk profile has changed
Determining whether regulatory trend reporting is required

Where the applicable regulatory criteria are met, the manufacturer must submit the appropriate trend report to the relevant Competent Authority.

Trend Analysis Should Lead to Action

The purpose of trend analysis is not simply to generate charts or calculate complaint rates.

Manufacturers should be able to demonstrate how trends are reviewed, how potential signals are investigated and what actions are taken when predefined thresholds or regulatory criteria are reached.

A typical process may look like:

PMS Data → Trending → Threshold Exceeded → Signal Investigation → Risk Assessment → Regulatory Assessment → CAPA / Reporting / Continued Monitoring

The findings should also feed back into the wider PMS system and, where relevant, the PMS Report or PSUR, risk management documentation, Clinical Evaluation, Performance Evaluation, PMCF or PMPF activities.

Effective trend analysis allows manufacturers to identify developing safety and performance problems earlier and take proportionate action before they result in more significant risks to patients or users.

Medical Device and IVD Vigilance: Serious Incident Reporting

Vigilance is a critical component of post-market surveillance. Where PMS identifies an incident involving a medical device or IVD, the manufacturer must assess whether the event meets the criteria for regulatory reporting to the relevant Competent Authority.

Under the EU MDR, serious incident reporting is primarily governed by Article 87. For IVDs, the corresponding requirements are established by Article 82 of the EU IVDR.

Manufacturers should have documented processes for identifying potentially reportable events, assessing them promptly and submitting reports within the applicable regulatory timelines.

What Is a Serious Incident?

Not every complaint or device malfunction is a serious incident.

Under the MDR and IVDR, a serious incident is an incident that directly or indirectly led, might have led, or might lead to:

The death of a patient, user or other person
The temporary or permanent serious deterioration of a person’s state of health
A serious public health threat

For IVDs, the assessment is particularly important because harm may occur indirectly.

An incorrect diagnostic result, for example, could lead to delayed treatment, inappropriate treatment, unnecessary intervention or failure to diagnose a serious condition. The fact that the IVD itself did not physically harm the patient does not necessarily mean that the event is not a serious incident.

Serious Incident Reporting Under the MDR and IVDR

Manufacturers must assess incidents to determine whether a causal relationship between the device and the serious incident has been established or is reasonably possible.

The standard reporting timelines under the MDR and IVDR are:

Type of Event	Maximum Reporting Timeline
Serious public health threat	Immediately, but no later than 2 days after awareness
Death or unanticipated serious deterioration in health	Immediately, but no later than 10 days after awareness
Other reportable serious incidents	Immediately once the causal relationship is established or reasonably possible, but no later than 15 days after awareness

These are maximum reporting periods, not target dates for manufacturers to routinely wait until before submitting a report.

The Regulations require reporting immediately once the relevant reporting criteria are established, subject to the applicable maximum timeframe.

What If the Manufacturer Does Not Yet Have All the Information?

Manufacturers should not delay regulatory reporting simply because an investigation has not been completed.

Where necessary to ensure timely reporting, an initial report may be submitted with incomplete information and followed by further information as the investigation progresses.

This allows the Competent Authority to be informed of a potentially significant safety issue while the manufacturer continues its technical, clinical or performance investigation.

Importantly, if the manufacturer is uncertain whether an incident is reportable, the MDR and IVDR require the manufacturer to submit a report within the applicable timeframe.

The Manufacturer's Investigation

Following notification of a serious incident, the manufacturer should investigate the event and determine its cause and significance.

Depending on the circumstances, the investigation may include:

Examination of the affected device
Review of batch or manufacturing records
Review of complaint history
Analysis of similar incidents
Technical or engineering investigation
Software investigation
Root cause analysis
Review of risk management documentation
Review of Clinical Evaluation or Performance Evaluation
Review of PMCF or PMPF findings
Assessment of similar devices
Evaluation of potential patient or user impact

The investigation should consider not only what happened in the individual case but also whether the event indicates a wider systemic problem.

Vigilance and Risk Management

Serious incidents provide important real-world information about the risks associated with a device.

Following an incident, manufacturers should consider whether:

The hazard was already identified
The sequence of events was adequately characterised
The probability of occurrence remains accurate
The severity of potential harm remains appropriate
Existing risk controls were effective
Additional risk control measures are required
A previously unidentified hazard has emerged
The overall benefit-risk determination remains acceptable

Where necessary, the risk management documentation should be updated to reflect the findings.

Vigilance and CAPA

A serious incident investigation may identify the need for Corrective and Preventive Action (CAPA).

Potential actions could include:

Changes to device design
Manufacturing process improvements
Supplier corrective actions
Software updates
Additional quality controls
Changes to labelling
Updates to the Instructions for Use
Additional user training
Changes to risk control measures
Additional PMCF or PMPF activities

Where the issue presents a risk associated with devices already on the market, a Field Safety Corrective Action may also be necessary.

Periodic Summary Reporting

Under certain circumstances, similar serious incidents involving the same device or device type may be eligible for Periodic Summary Reporting rather than being reported individually.

This may be possible where, for example, the root cause has been identified, an FSCA has been implemented, or the incidents are common and well documented.

Periodic Summary Reporting should not simply be adopted by the manufacturer as an internal reporting strategy. Its use, format, content and reporting frequency are subject to agreement with the relevant Competent Authority in accordance with the applicable regulatory framework.

Vigilance Is Part of the Wider PMS System

Vigilance should not operate as an isolated regulatory process.

Information generated through serious incident reporting and investigation should feed back into the manufacturer’s wider post-market surveillance activities.

A typical pathway may be:

Complaint or PMS Signal → Incident Assessment → Serious Incident Report → Investigation → Risk Assessment → CAPA / FSCA → PMS & Technical Documentation Update

Relevant findings should be considered when updating:

Risk management documentation
PMS Reports
PSURs
Clinical Evaluation
Performance Evaluation
PMCF or PMPF documentation
PMS Plans
Labelling and Instructions for Use
CAPA records
Technical documentation

Effective vigilance therefore does more than fulfil a regulatory reporting obligation. It enables manufacturers and Competent Authorities to identify significant safety and performance issues, investigate their causes and take appropriate action to protect patients, users and public health.

Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN)

Where post-market surveillance or vigilance activities identify an unacceptable risk associated with devices already placed on the market, the manufacturer may need to implement a Field Safety Corrective Action (FSCA).

An FSCA is an action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident associated with a device made available on the market.

FSCAs can apply to both medical devices under the EU MDR and IVDs under the EU IVDR and form an important connection between post-market surveillance, vigilance, risk management and corrective action.

What Actions Can an FSCA Include?

An FSCA does not necessarily mean that every affected device must be recalled.

Depending on the nature of the safety issue, an FSCA may involve:

Returning a device to the manufacturer or supplier
Recalling affected devices
Exchanging or replacing devices
Modifying a device
Performing a software or firmware update
Retrofitting devices already in use
Introducing additional inspections or testing
Changing the Instructions for Use
Updating warnings, precautions or contraindications
Providing additional user or healthcare professional training
Changing how a device should be used
Providing specific advice concerning the clinical management of patients
Providing additional instructions for the handling or interpretation of IVD results

The appropriate action should be determined through investigation and risk assessment.

When Might an FSCA Be Required?

An FSCA may become necessary following information identified through:

Serious incident investigations
Complaint trending
PMS signal detection
PMCF or PMPF findings
Product testing
Manufacturing investigations
CAPA
Scientific literature
Information concerning similar devices
Competent Authority enquiries
Newly identified risks

The manufacturer should assess whether the identified issue affects devices that have already been distributed and whether action is required to prevent or reduce the associated risk.

For example, an investigation may identify that a particular batch of devices has an increased probability of failure. If affected devices have already been supplied to customers, corrective action within the manufacturing facility alone may not adequately control the risk. Action may also be required in the field.

Reporting an FSCA

Under the MDR and IVDR vigilance frameworks, manufacturers are required to report FSCAs undertaken in the Union unless the action concerns only devices made available outside the Union and the reason for the action is limited to those devices.

Where an FSCA is required, the manufacturer should communicate with the relevant Competent Authority in accordance with the applicable vigilance requirements.

Except in urgent situations where immediate action is necessary because of the risk to patients or users, the manufacturer should generally report the FSCA before it is undertaken.

Manufacturers should maintain documented procedures to ensure that potential FSCAs are appropriately assessed, escalated and reported.

What Is a Field Safety Notice?

A Field Safety Notice (FSN) is the communication used by the manufacturer to provide information about an FSCA to users, customers or other affected parties.

The FSN should clearly explain the safety issue and the actions recipients are expected to take.

Depending on the situation, recipients might include:

Hospitals
Healthcare professionals
Laboratories
Distributors
Importers
Pharmacies
Device users
Other organisations holding affected products

The objective is to ensure that affected parties understand both the risk and the action required to reduce it.

What Should a Field Safety Notice Include?

The content will depend on the particular FSCA, but an effective FSN should clearly identify:

The affected device or IVD
Relevant product names and identifiers
Affected model, catalogue, batch or lot numbers, where applicable
The reason for the safety action
A clear description of the identified problem
The associated hazard or risk
Actions the recipient must take
Actions being taken by the manufacturer
Instructions for identifying affected devices
Instructions concerning return, modification, disposal or continued use, where applicable
Appropriate contact information

The notice should be written so that the intended recipients can clearly understand the issue and what they need to do.

The message should not minimise the level of risk in an attempt to protect the manufacturer’s commercial reputation.

FSCAs for IVDs

Field safety action for an IVD may require different considerations from action involving a conventional medical device.

An IVD issue may affect the accuracy or interpretation of results rather than causing direct physical harm.

For example, an FSCA could be necessary because of:

Increased false-negative results
Increased false-positive results
Incorrect calibration
Reagent instability
Incorrect reference ranges
Software calculation errors
Interference or cross-reactivity
Incorrect result interpretation
Labelling or Instructions for Use errors

Manufacturers may therefore need to consider not only the affected IVDs but also results previously generated using those products.

Depending on the risk, healthcare professionals or laboratories may need guidance concerning retesting, review of previous results or clinical follow-up.

Verifying the Effectiveness of an FSCA

Implementing an FSCA is not necessarily the end of the process.

Manufacturers should monitor whether the corrective action has been successfully implemented and whether it has adequately controlled the identified risk.

This may include monitoring:

Customer acknowledgement of the FSN
Return or replacement rates
Completion of device modifications
Installation of software updates
Completion of required user actions
Subsequent complaint and incident rates
Effectiveness of revised risk controls

If the action is not achieving the intended result, further measures may be necessary.

Feeding FSCA Findings Back Into PMS

An FSCA provides significant post-market information and should therefore feed back into the manufacturer’s wider regulatory documentation.

Relevant documents and processes may need to be updated, including:

Risk management documentation
PMS Plan
PMS Report
PSUR
Clinical Evaluation
Performance Evaluation
PMCF or PMPF documentation
CAPA
Instructions for Use and labelling
Design or manufacturing documentation
Technical documentation

The overall process can be viewed as:

PMS Signal or Incident → Investigation → Risk Assessment → FSCA → Field Safety Notice → Effectiveness Monitoring → PMS & Technical Documentation Update

An effective FSCA process ensures that when a significant safety or performance issue is identified after market introduction, appropriate action reaches the devices, users and patients potentially affected by that issue.

Post-Market Surveillance Reports (PMS Reports)

The Post-Market Surveillance Report is one of the key documented outputs of the manufacturer’s post-market surveillance system.

It provides a structured summary of the results and conclusions generated from PMS activities and records any preventive or corrective actions taken as a result.

Under the EU MDR, the PMS Report is required for Class I medical devices under Article 85.

Under the EU IVDR, the PMS Report is required for Class A and Class B IVDs under Article 80.

Higher-risk devices require a Periodic Safety Update Report (PSUR) instead, which we cover in the next section.

Which Devices Require a PMS Report?

The requirements can be summarised as follows:

Regulation	Device Classification	Required PMS Document
EU MDR	Class I	PMS Report
EU MDR	Class IIa, IIb and III	PSUR
EU IVDR	Class A and B	PMS Report
EU IVDR	Class C and D	PSUR

This distinction is important because manufacturers should determine the required PMS output based on the applicable Regulation and classification of the device.

What Should a PMS Report Contain?

The MDR and IVDR require the PMS Report to summarise the results and conclusions of the analysis of post-market surveillance data gathered as a result of the PMS Plan.

It should also include a rationale and description of any preventive and corrective actions taken.

In practice, an effective PMS Report may address areas such as:

Device identification and scope
Reporting or review period
PMS activities undertaken
Sales, distribution or exposure information, where relevant
Complaint data
Complaint and failure rates
Serious and non-serious incidents
Vigilance activities
Trend analysis
Field Safety Corrective Actions
CAPA arising from post-market information
Scientific and technical literature
Feedback from users, distributors and importers
Information concerning similar devices
PMCF findings for medical devices, where applicable
PMPF findings for IVDs, where applicable
New or emerging safety and performance information
Review of risk management implications
Review of the benefit-risk determination
Preventive or corrective actions taken
Overall conclusions concerning continued safety and performance

The precise structure should be appropriate for the device and consistent with the activities established within the PMS Plan.

PMS Report and the PMS Plan

The PMS Plan and PMS Report serve different purposes.

The PMS Plan defines what the manufacturer intends to do.

The PMS Report documents what the manufacturer found.

A simple way to distinguish them is:

PMS Plan → Data Collection & Analysis → PMS Report

The PMS Report should therefore provide evidence that the surveillance activities established in the PMS Plan have actually been performed and that the resulting information has been evaluated.

If the PMS Plan identifies complaint trending, literature surveillance, user feedback and PMCF or PMPF as relevant activities, the PMS Report should appropriately address the results of those activities.

How Often Should a PMS Report Be Updated?

Unlike PSURs, Articles 85 MDR and 80 IVDR do not establish a fixed annual or biennial reporting frequency.

Instead, the PMS Report must be updated when necessary.

Manufacturers should therefore establish an appropriate review and update process based on factors such as:

Device risk
Volume of devices placed on the market
Complaint and incident history
Changes in safety or performance
New risks or safety signals
PMCF or PMPF findings
Changes in the state of the art
Corrective or preventive actions
Significant changes affecting the device

The absence of a fixed statutory reporting interval should not be interpreted as meaning that the PMS Report can remain unchanged indefinitely.

Manufacturers should be able to demonstrate that PMS information is being reviewed on an ongoing basis and that the report is updated when the results or conclusions of the surveillance process make an update necessary.

PMS Reports for Class I Medical Devices

For Class I devices under the MDR, the PMS Report provides an important record of continued post-market oversight.

This includes Class I devices that do not require a PSUR.

The report should demonstrate that the manufacturer continues to evaluate the real-world safety and performance of the device following market introduction.

Where applicable, findings should be linked with:

Risk management
Clinical Evaluation
PMCF
Complaint handling
CAPA
Vigilance
Technical documentation

A lower device classification does not remove the manufacturer’s obligation to conduct meaningful post-market surveillance.

PMS Reports for Class A and Class B IVDs

Under the IVDR, Class A and Class B IVDs require a PMS Report under Article 80.

The same fundamental principle applies: the report should summarise and evaluate the information collected through the PMS system and document relevant conclusions and actions.

For IVDs, particular consideration may need to be given to performance-related information such as:

Erroneous results
False-positive and false-negative results
Invalid or indeterminate results
Reagent or calibration issues
Stability concerns
Interferences or cross-reactivity
Changes in analytical or clinical performance
PMPF findings

Relevant findings should feed back into the Performance Evaluation, risk management and other applicable technical documentation.

The PMS Report Is a Living Regulatory Document

A PMS Report should not simply be prepared to satisfy an audit or technical documentation checklist.

It should provide a meaningful assessment of whether the post-market evidence continues to support the safety and performance of the device.

Where the data identifies a potential problem, the report should explain how the issue was assessed and what action was taken.

This creates a clear regulatory pathway:

PMS Plan → Post-Market Data → Analysis → PMS Report → Risk & Evidence Update → Corrective Action, Where Necessary

The PMS Report therefore provides documented evidence that the manufacturer’s post-market surveillance system is operating effectively and that real-world information is being used to maintain the safety, performance and regulatory compliance of the device.

Periodic Safety Update Reports (PSURs)

The Periodic Safety Update Report (PSUR) is the principal post-market surveillance report required for higher-risk medical devices and IVDs.

Unlike the PMS Report used for lower-risk devices, a PSUR provides a more comprehensive and regularly updated assessment of post-market data, benefit-risk conclusions, sales and usage information, and post-market follow-up activities.

Under the EU MDR, PSUR requirements are established by Article 86 for Class IIa, Class IIb and Class III medical devices.

Under the EU IVDR, Article 81 requires PSURs for Class C and Class D IVDs.

Which Devices Require a PSUR?

The applicable requirements can be summarised as follows:

Regulation	Device Classification	PSUR Update Frequency
EU MDR	Class IIa	When necessary and at least every 2 years
EU MDR	Class IIb	At least annually
EU MDR	Class III	At least annually
EU IVDR	Class C	At least annually
EU IVDR	Class D	At least annually

These are minimum regulatory update frequencies. A PSUR may need to be updated sooner where significant new post-market information affects the safety, performance or benefit-risk profile of the device.

What Must a PSUR Contain?

The PSUR should summarise the results and conclusions of the analysis of post-market surveillance data gathered through implementation of the PMS Plan.

Under the MDR and IVDR, the PSUR must include, as applicable:

The conclusions of the benefit-risk determination
The main findings of PMCF for medical devices or PMPF for IVDs
The volume of device sales
An estimate of the size and other characteristics of the population using the device
Where practicable, the usage frequency of the device

The PSUR should also provide a clear overview of the significant PMS information generated during the reporting period.

Depending on the device and available data, this may include:

Complaint and incident data
Complaint and failure rates
Serious incidents
Trend analysis
Vigilance reporting
Field Safety Corrective Actions
CAPA arising from PMS activities
Scientific and technical literature
User, distributor and importer feedback
Information concerning similar devices
New or emerging risks
Changes in the state of the art
PMCF or PMPF findings
Changes to risk management
Changes to Clinical Evaluation or Performance Evaluation
Preventive and corrective actions taken

The report should provide an overall assessment of whether the available post-market evidence continues to support the safety, performance and acceptable benefit-risk profile of the device.

PSUR and Benefit-Risk Determination

One of the most important elements of a PSUR is the updated benefit-risk determination.

Manufacturers should assess whether information collected during the reporting period changes any of the assumptions or conclusions previously established within the risk management and clinical or performance documentation.

For example, PMS data may indicate:

A higher frequency of a known risk
Greater severity of harm than previously anticipated
A previously unidentified risk
Deterioration in device performance
New information concerning long-term safety
Changes in clinical practice or the state of the art
New information concerning alternative devices or treatments
Changes in diagnostic performance for an IVD

Where new information affects the benefit-risk determination, the manufacturer should document the assessment and determine whether further action is necessary.

Sales, Population and Usage Data

The MDR and IVDR require PSURs to include information concerning the volume of device sales and an estimate of the size and characteristics of the population using the device.

Where practicable, the manufacturer should also include information concerning usage frequency.

This information provides important context for interpreting complaints, incidents and other PMS data.

For example, 50 reported incidents cannot be meaningfully evaluated without understanding whether the device was used 5,000 times or five million times.

Appropriate exposure information may therefore include:

Units sold or distributed
Number of devices in active use
Number of procedures
Number of tests performed
Estimated number of patients exposed
Geographic distribution
Usage frequency

The most appropriate denominator will depend on the type of device and the information reasonably available to the manufacturer.

PMCF Findings in MDR PSURs

For medical devices, the PSUR must include the main findings of Post-Market Clinical Follow-up.

PMCF provides proactive clinical evidence concerning the continued safety and performance of the device and can help identify previously unknown risks, confirm known risks and address uncertainties within the Clinical Evaluation.

Relevant PMCF findings should therefore be considered alongside complaints, incidents, literature and other PMS information when reaching the overall conclusions of the PSUR.

PMPF Findings in IVDR PSURs

For Class C and Class D IVDs, the PSUR must include the main findings of Post-Market Performance Follow-up.

PMPF provides ongoing information concerning the performance and scientific data associated with an IVD during its post-market lifecycle.

The findings may provide important evidence concerning:

Continued analytical performance
Continued clinical performance
Scientific validity
Emerging performance limitations
False-positive or false-negative results
Changes in the target population
Changes in the state of the art
New interferences or cross-reactivities

These findings should be considered when determining whether the Performance Evaluation and benefit-risk conclusions remain valid.

PSURs for Class III and Implantable Medical Devices

For Class III and implantable medical devices, the MDR establishes additional requirements for PSUR review.

The manufacturer must submit PSURs for these devices through the electronic system referred to in Article 92.

The Notified Body involved in the conformity assessment reviews the PSUR and adds its evaluation to the electronic system, together with details of any action taken.

The PSUR and the Notified Body’s evaluation are then made available to the relevant Competent Authorities through that system.

PSURs for Class D IVDs

The IVDR establishes a comparable requirement for Class D IVDs.

Manufacturers of Class D devices must submit the PSUR through the electronic system referred to in Article 87.

The Notified Body reviews the report and adds its evaluation to the electronic system, together with details of any action taken.

The PSUR and the Notified Body’s evaluation are then made available to Competent Authorities through that system.

PSURs for Other Devices

For MDR Class IIa and Class IIb devices that do not fall within the specific electronic submission requirement for Class III or implantable devices, the PSUR must form part of the technical documentation and be made available to the Notified Body involved in conformity assessment and, upon request, to Competent Authorities.

For Class C IVDs, the PSUR similarly forms part of the technical documentation and must be made available to the Notified Body and Competent Authorities upon request.

Manufacturers should therefore ensure that PSURs remain current, controlled and readily available.

A PSUR Should Tell the Device's Post-Market Safety Story

A strong PSUR should not simply reproduce tables of complaints, incidents and sales figures.

It should interpret the information and explain what the post-market evidence means for the device.

A useful way of viewing the process is:

PMS Data → Analysis & Trending → PMCF/PMPF → Benefit-Risk Review → PSUR → Regulatory & Quality Actions

The reader should be able to understand:

What happened during the reporting period
Whether any meaningful trends or signals were identified
Whether new risks emerged
Whether known risks changed
What PMCF or PMPF demonstrated
Whether the benefit-risk profile remains acceptable
What corrective or preventive actions were taken
Whether further surveillance or investigation is required

The PSUR therefore acts as a periodic consolidated assessment of the real-world safety and performance of higher-risk medical devices and IVDs throughout their post-market lifecycle.

PMCF and PMPF: Post-Market Follow-up Under the MDR and IVDR

Post-market follow-up provides manufacturers with a proactive way of collecting additional evidence about a device after it has been placed on the market.

For medical devices under the EU MDR, this is known as Post-Market Clinical Follow-up (PMCF). For IVDs under the EU IVDR, the equivalent process is Post-Market Performance Follow-up (PMPF).

EU MDR – Medical Devices	EU IVDR – IVDs
Post-Market Clinical Follow-up (PMCF)	Post-Market Performance Follow-up (PMPF)
Supports Clinical Evaluation	Supports Performance Evaluation
Collects and evaluates clinical data	Collects and evaluates performance and scientific data
Findings feed into the CER	Findings feed into the PER
Main findings feed into the PSUR, where applicable	Main findings feed into the PSUR, where applicable

Post-Market Clinical Follow-up (PMCF)

PMCF is a continuous process that updates the Clinical Evaluation for a medical device.

PMCF activities are used to proactively collect and evaluate clinical data from the use of a CE-marked device within its intended purpose. The objective is to confirm continued safety and performance, identify previously unknown side effects, monitor identified risks and detect emerging risks.

Depending on the device, PMCF activities may include:

PMCF studies
Patient or user surveys
Device registries
Real-world clinical data
Follow-up of patients previously enrolled in clinical investigations
Review of relevant clinical experience

PMCF findings should feed back into the Clinical Evaluation, risk management, PMS documentation and PSUR, where applicable.

Post-Market Performance Follow-up (PMPF)

PMPF performs a similar lifecycle function for IVDs.

Under the IVDR, PMPF is a continuous process that updates the Performance Evaluation and is used to proactively collect and evaluate performance and relevant scientific data from the use of the IVD.

PMPF can help manufacturers confirm continued:

Scientific validity
Analytical performance
Clinical performance
Safety and performance
Acceptability of identified risks
Benefit-risk conclusions

PMPF may also identify new performance limitations, emerging risks, changes in the state of the art or issues such as unexpected false-positive or false-negative results.

The findings should be documented and fed back into the Performance Evaluation, risk management and wider PMS system.

PMCF and PMPF Are Part of PMS

PMCF and PMPF should not operate as isolated activities.

They form part of the manufacturer’s wider post-market surveillance system and create an important link between real-world evidence and the technical documentation:

Medical Devices: PMS → PMCF → Clinical Evaluation → Risk Management

IVDs: PMS → PMPF → Performance Evaluation → Risk Management

This continuous feedback helps manufacturers demonstrate that their devices remain safe, perform as intended and continue to have an acceptable benefit-risk profile throughout their lifecycle.

PMS, Risk Management and Clinical or Performance Evaluation

Post-market surveillance does not operate in isolation. Information collected after a medical device or IVD is placed on the market must feed back into the manufacturer’s risk management and clinical or performance evaluation processes.

This creates a continuous lifecycle approach in which real-world evidence is used to confirm whether the assumptions made before market access remain valid.

PMS and Risk Management

Risk management should continue throughout the entire lifecycle of the device.

PMS data may identify:

New or previously unidentified hazards
Changes in the frequency or severity of known risks
New sequences of events leading to harm
Ineffective risk control measures
Changes in the state of the art
New information affecting the benefit-risk determination

Where relevant, these findings should be evaluated and the risk management documentation updated.

ISO 14971 provides the internationally recognised framework for applying risk management to medical devices, including the production and post-production phases.

PMS and Clinical Evaluation

For medical devices under the MDR, PMS information contributes to the ongoing Clinical Evaluation.

Relevant complaints, incidents, literature, PMCF findings and other real-world information should be considered when determining whether the clinical evidence continues to support the device’s safety, clinical performance and benefit-risk profile.

Where significant new information becomes available, the Clinical Evaluation Report (CER) should be updated as appropriate.

PMS and Performance Evaluation

For IVDs under the IVDR, post-market information similarly feeds into the Performance Evaluation.

PMS and PMPF findings may provide new information concerning:

Scientific validity
Analytical performance
Clinical performance
Performance limitations
Erroneous results
Emerging risks
Changes in the state of the art

Relevant findings should be reflected in the Performance Evaluation Report (PER) and associated risk management documentation.

Creating a Continuous Feedback Loop

An effective PMS system therefore creates an ongoing relationship between post-market evidence, risk management and the manufacturer’s technical documentation:

Medical Devices: PMS → PMCF → Clinical Evaluation → Risk Management → PMS

IVDs: PMS → PMPF → Performance Evaluation → Risk Management → PMS

This feedback loop helps ensure that the evidence supporting a device remains current throughout its lifecycle and that new safety or performance information results in appropriate regulatory and quality action.

Post-Market Surveillance Under the UK MDR

Manufacturers placing medical devices and IVDs on the market in Great Britain must also consider the post-market surveillance requirements of the UK Medical Devices Regulations 2002 (UK MDR).

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduced a new Part 4A into the UK MDR, significantly strengthening and clarifying the PMS requirements applicable in Great Britain.

These requirements came into force on 16 June 2025 and apply to medical devices, including IVDs, placed on the market or put into service in Great Britain from that date.

What Do the GB PMS Requirements Cover?

Manufacturers must establish a PMS system capable of gathering and analysing information about the safety, quality and performance of their devices.

This includes requirements covering:

A documented PMS system
A PMS Plan
Collection and analysis of post-market information
Complaints and feedback
Risk management
Preventive and corrective actions
Vigilance reporting
Trend reporting
Field Safety Corrective Actions
PMS Reports (PMSRs)
Periodic Safety Update Reports (PSURs)

Manufacturers must regularly review the actions undertaken according to the PMS Plan and document the results within the appropriate PMSR or PSUR.

Which Devices Require a PMSR or PSUR in Great Britain?

The GB requirements apply reporting obligations according to device risk classification.

Lower-risk devices generally require a Post-Market Surveillance Report (PMSR), while higher-risk devices require a Periodic Safety Update Report (PSUR).

This includes requirements for both medical devices and IVDs.

For example, Class I medical devices and Class A or B IVDs generally require a PMSR, while Class II and III medical devices and Class C or D IVDs require a PSUR.

The MHRA also specifies minimum update periods for these reports, so manufacturers supplying both the EU and GB markets should ensure that their PMS reporting schedules satisfy the requirements applicable in each jurisdiction.

CE-Marked Devices Are Also Within Scope

The GB PMS requirements are not limited to UKCA-marked devices.

They apply to relevant medical devices placed on the market or put into service in Great Britain from 16 June 2025 regardless of whether the device relies on CE marking or UKCA marking for GB market access.

Manufacturers using CE marking to access the GB market should therefore ensure that their post-market processes also satisfy applicable UK MDR requirements rather than assuming EU MDR or IVDR compliance automatically addresses every GB obligation.

Role of the UK Responsible Person

Where a manufacturer is located outside the UK and has appointed a UK Responsible Person (UKRP), the UKRP also has responsibilities within the post-market framework.

In particular, the UKRP must immediately inform the manufacturer of complaints or reports it receives relating to devices for which it has been appointed.

Manufacturers and UK Responsible Persons should therefore have effective communication processes to ensure that relevant post-market information is promptly transferred, assessed and, where necessary, reported to the MHRA.

Great Britain and Northern Ireland Have Different Frameworks

It is important to distinguish between Great Britain and Northern Ireland.

The strengthened UK MDR PMS requirements apply in Great Britain: England, Scotland and Wales.

Medical devices placed on the market or put into service in Northern Ireland continue to follow the applicable EU MDR and EU IVDR post-market surveillance requirements.

Manufacturers supplying devices across the UK should therefore determine which regulatory framework applies to each market and ensure that their PMS system accommodates the relevant requirements.

For manufacturers operating across both the UK and EU, an integrated PMS system can often reduce duplication. However, the applicable reporting requirements, timelines and regulatory responsibilities for each jurisdiction must still be identified and satisfied.

PMS Compliance Checklist for Medical Device and IVD Manufacturers

An effective post-market surveillance system should be planned, documented and integrated with the manufacturer’s wider quality and regulatory processes.

Manufacturers can use the following checklist as a high-level review of their PMS arrangements.

PMS Compliance Checklist

📄

Download the Post-Market Surveillance Compliance Checklist

Use our practical PMS checklist to review your post-market surveillance system against key EU MDR, EU IVDR and UK MDR requirements.

Download the PMS Compliance Checklist

Common PMS Mistakes to Avoid

Even where a manufacturer has established PMS procedures, weaknesses in implementation can reduce the effectiveness of the system.

Common problems include:

Treating PMS as an annual report rather than a continuous process
Relying solely on complaints instead of proactively collecting post-market information
Using generic PMS Plans that are not specific to the device and its risks
Collecting data without establishing meaningful methods for analysis
Trending raw complaint numbers without considering sales or device exposure
Failing to define appropriate indicators and thresholds
Failing to investigate emerging signals
Poor communication between complaint handling, vigilance, risk management and CAPA processes
Failing to consider information concerning similar devices
Inadequate PMCF or PMPF activities
Failing to update the Clinical Evaluation or Performance Evaluation following relevant PMS findings
Failing to update risk management when new post-market information becomes available
Preparing PMS Reports or PSURs that summarise data without critically evaluating what the findings mean
Failing to document why corrective action was or was not considered necessary

The key principle is that PMS should demonstrate a continuous process of collection, analysis, evaluation and action.

Manufacturers should be able to show a clear pathway from the information received from the market through to the conclusions reached and, where necessary, the actions taken:

Post-Market Data → Analysis → Signal Detection → Risk Assessment → Action → Documentation Update → Continued Monitoring

A well-designed PMS system does more than satisfy a regulatory requirement. It provides manufacturers with an ongoing mechanism for identifying emerging risks, maintaining current technical documentation and demonstrating that their medical devices and IVDs continue to be safe and perform as intended throughout their lifecycle.

How Patient Guard Can Help With Post-Market Surveillance

Post-market surveillance requires more than preparing a PMS Plan or completing a report. Manufacturers need an effective lifecycle system that connects PMS data with vigilance, risk management, clinical or performance evaluation and ongoing regulatory compliance.

Patient Guard supports medical device and IVD manufacturers with the development, implementation and maintenance of post-market surveillance activities under the EU MDR, EU IVDR and UK MDR.

Our regulatory specialists can support manufacturers with:

Post-Market Surveillance Plans
Post-Market Surveillance Reports (PMS Reports/PMSRs)
Periodic Safety Update Reports (PSURs)
Post-Market Clinical Follow-up (PMCF) Plans and Reports
Post-Market Performance Follow-up (PMPF) Plans and Reports
Complaint and PMS data analysis
Trend analysis and signal evaluation
Vigilance and serious incident assessment
Field Safety Corrective Actions (FSCAs)
Clinical Evaluation and CER updates
IVD Performance Evaluation and PER updates
ISO 14971 risk management
PMS procedures and quality management system integration
EU Authorised Representative services
UK Responsible Person services

Whether you are establishing a PMS system for a new device, preparing an upcoming PSUR, addressing gaps identified during a Notified Body review or bringing existing post-market documentation into compliance, Patient Guard can provide practical regulatory support tailored to your device and market.

Need Support With Your PMS Documentation?

If you need help preparing or reviewing a PMS Plan, PMS Report, PSUR, PMCF, PMPF or associated post-market documentation, speak with the Patient Guard team.

We support medical device and IVD manufacturers across the EU and UK with practical, proportionate post-market surveillance solutions designed around their devices, risk classification and regulatory requirements.

Frequently Asked Questions About Medical Device PMS

1. What is post-market surveillance (PMS) for medical devices?

Post-market surveillance (PMS) is the systematic process of collecting, analysing and evaluating information about a medical device after it has been placed on the market. It enables manufacturers to monitor real-world safety and performance, identify emerging risks and demonstrate ongoing compliance with regulations such as the EU MDR and UK MDR.

2. Is post-market surveillance required under the EU MDR?

Yes. Articles 83–86 of the EU Medical Device Regulation (EU MDR 2017/745) require manufacturers to establish, document and maintain a post-market surveillance system that is appropriate for the device's risk class. The system must continuously collect and evaluate post-market data throughout the product lifecycle.

3. What is included in a Post-Market Surveillance (PMS) Plan?

A PMS Plan typically defines how the manufacturer will collect, review and analyse post-market data. It should include the surveillance objectives, data sources, complaint handling procedures, trend analysis methods, vigilance activities, PMCF requirements, responsibilities and links to risk management and clinical evaluation.

4. What is the difference between a PMS Report and a PSUR?

A PMS Report is generally prepared for Class I medical devices and summarises the results of post-market surveillance activities. A Periodic Safety Update Report (PSUR) is required for Class IIa, IIb and III devices and provides a more comprehensive review of safety, performance, benefit-risk assessment and post-market clinical data.

5. How does post-market surveillance differ from complaint handling?

Complaint handling is only one part of a post-market surveillance system. PMS also includes trend analysis, literature reviews, vigilance reporting, Post-Market Clinical Follow-up (PMCF), customer feedback, risk management updates and continuous evaluation of device performance.

6. What is the relationship between PMS and Post-Market Clinical Follow-up (PMCF)?

PMCF is a component of the overall post-market surveillance system. While PMS gathers information from a wide range of sources, PMCF focuses on collecting additional clinical evidence after market placement to confirm the device continues to achieve its intended purpose and maintains an acceptable benefit-risk profile.

7. How does post-market surveillance support ISO 14971 risk management?

Information collected through PMS is used to verify existing risk control measures, identify previously unknown hazards and update the Risk Management File. This ensures that risk management remains an ongoing process throughout the entire lifecycle of the medical device.

8. What types of information should manufacturers collect during post-market surveillance?

Manufacturers should collect information from multiple sources, including customer complaints, adverse events, serious incidents, PMCF studies, scientific literature, healthcare professional feedback, distributor reports, device returns, service records and trend analysis. Using multiple data sources provides a more complete understanding of device performance.

9. What happens if a manufacturer does not have an effective PMS system?

An inadequate PMS system can result in non-conformities during Notified Body audits, delays in certification, regulatory enforcement action or increased risks to patient safety. Manufacturers may also fail to identify emerging safety issues before they become significant problems.

10. Can Patient Guard help with post-market surveillance compliance?

Yes. Patient Guard supports manufacturers with the development and maintenance of compliant Post-Market Surveillance systems, including PMS Plans, PMS Reports, PSURs, PMCF documentation, vigilance procedures, risk management updates and Clinical Evaluation Reports to help maintain compliance with the EU MDR and UK MDR.

References

This guide is based on the following legislation, international standards and official regulatory guidance relating to post-market surveillance for medical devices and in vitro diagnostic medical devices under the EU MDR, EU IVDR and UK MDR.

Organisation	Reference	Why it's relevant
European Union	Regulation (EU) 2017/745 on Medical Devices (MDR)	Establishes the legal requirements for post-market surveillance of medical devices, including PMS systems, PMS Plans, PMS Reports, PSURs, vigilance and trend reporting.
European Union	Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)	Establishes the corresponding post-market surveillance requirements for IVDs, including PMS systems, PMS Plans, PMS Reports, PSURs, PMPF, vigilance and trend reporting.
European Commission / MDCG	MDCG 2025-10 – Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices	Provides dedicated MDCG guidance on the implementation of post-market surveillance requirements for medical devices and IVDs under the MDR and IVDR.
European Commission / MDCG	MDCG 2023-3 Rev. 2 – Questions and Answers on Vigilance Terms and Concepts	Provides official guidance on vigilance terminology and concepts under the MDR and IVDR, including incidents, serious incidents, reporting requirements and Field Safety Corrective Actions.
European Commission / MDCG	MDCG Endorsed Documents and Other Guidance	Provides the European Commission's collection of MDCG guidance supporting implementation of the MDR and IVDR, including post-market surveillance, vigilance and PSUR guidance.
UK Government / MHRA	Medical Devices: Post-Market Surveillance Requirements	Provides official MHRA guidance on the strengthened post-market surveillance requirements applicable to medical devices and IVDs placed on the market in Great Britain.
UK Government	Medical Devices Regulations 2002 (UK MDR)	Provides the statutory regulatory framework governing medical devices and IVDs in Great Britain, including applicable post-market surveillance requirements.
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, including the evaluation of production and post-production information throughout the device lifecycle.
International Organization for Standardization (ISO)	ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes	Defines internationally recognised quality management system requirements relevant to feedback, complaint handling, regulatory reporting, corrective action and post-market processes.

Medical device and IVD legislation, guidance and regulatory expectations continue to evolve. Manufacturers should always consult the latest applicable legislation, recognised standards and official regulatory guidance when establishing and maintaining their post-market surveillance systems.

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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Post-Market Surveillance (PMS) for Medical Devices and IVDs

Post-Market Surveillance for Medical Devices and IVDs

Looking for a Complete Guide to the EU MDR?

Looking for a Complete Guide to the EU IVDR?

Post-Market Surveillance Requirements: EU MDR vs EU IVDR

Which PMS Report Does Your Device Require?

What Is Post-Market Surveillance (PMS)?

PMS Is a Continuous Lifecycle Process

From Reactive Monitoring to Proactive Surveillance

Understand Your Post-Market Surveillance Obligations

Why Is Post-Market Surveillance Important?

Protecting Patients and Users

Identifying Emerging Risks and Trends

Confirming Continued Safety and Performance

Maintaining an Acceptable Benefit-Risk Profile

Driving Corrective Action and Product Improvement

Supporting Continued Regulatory Compliance

Building a Post-Market Surveillance System Under the MDR and IVDR

What Should a PMS System Include?

PMS Must Be Proportionate to the Device

PMS Responsibilities Should Be Clearly Defined

The PMS System Must Produce Actionable Information

PMS Should Operate as a Feedback Loop

The Post-Market Surveillance Plan (PMS Plan)

What Should a PMS Plan Include?

Proactive and Reactive PMS Data

Methods for Assessing PMS Data

PMS Plan and Risk Management

PMS Plan and PMCF for Medical Devices

PMS Plan and PMPF for IVDs

The PMS Plan Should Be Device-Specific

Post-Market Surveillance Data: What Should Manufacturers Collect?

Complaints and Customer Feedback

Serious and Non-Serious Incidents

Product Returns, Failures and Service Data

Feedback from Users, Distributors and Importers

Scientific and Technical Literature

Databases and Registries

Information About Similar Devices and IVDs

PMCF and PMPF Data

Sales, Distribution and Exposure Data

PMS Data Should Be Analysed, Not Simply Collected

Looking for a Complete Guide to ISO 13485?

Complaint Handling and Post-Market Surveillance

What Is a Medical Device or IVD Complaint?

Every Complaint Should Be Evaluated

Complaint Investigation

Complaints and Vigilance Reporting

Complaint Trending and Signal Detection

Complaints and Trend Reporting

Complaints and CAPA

Feeding Complaint Data Back Into PMS and Risk Management

Trend Reporting and Signal Detection Under the MDR and IVDR

What Is Trend Reporting?

Routine PMS Trending vs Regulatory Trend Reporting

Establishing Indicators and Threshold Values

Why Denominator Data Matters

Establishing an Observation Period

Signal Detection

What Happens When a Trend Is Identified?

Trend Analysis Should Lead to Action

Medical Device and IVD Vigilance: Serious Incident Reporting

What Is a Serious Incident?

Serious Incident Reporting Under the MDR and IVDR

What If the Manufacturer Does Not Yet Have All the Information?

The Manufacturer's Investigation

Vigilance and Risk Management

Vigilance and CAPA

Periodic Summary Reporting

Vigilance Is Part of the Wider PMS System

Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN)

What Actions Can an FSCA Include?

When Might an FSCA Be Required?

Reporting an FSCA

What Is a Field Safety Notice?

What Should a Field Safety Notice Include?

FSCAs for IVDs

Verifying the Effectiveness of an FSCA

Feeding FSCA Findings Back Into PMS

Post-Market Surveillance Reports (PMS Reports)