MDR Post-Market Surveillance

Updated July 2026

MDR post-market surveillance is the system through which the manufacturer collects, records and analyses information on the device after it has been placed on the market.

This guide explains, for informational purposes, what Regulation (EU) 2017/745 provides in relation to post-market surveillance, what role is played by the PMS system, PMS plan, PMS report, PSUR and PMCF, and how these elements are connected to the life of the device on the market.

In the MDR context, post-market surveillance is often referred to using the acronym PMS.

Sheet with the title Post-Market Surveillance Regulation (EU) 2017/745

In this guide

What does MDR post-market surveillance mean?

MDR post-market surveillance refers to the activities carried out after a medical device has been placed on the market or put into service.

In general terms, it is not only about collecting complaints or reports in a reactive way. The PMS system must enable the manufacturer to actively and systematically collect and analyse relevant data on the quality, performance and safety of the device throughout its entire lifetime.

These data may come from the real-world use of the device on the market, feedback from users or healthcare professionals, reports from economic operators, technical or scientific literature, registries, databases, complaints, incidents and information on similar devices.

Post-market surveillance is therefore a continuous process. It helps verify that the device continues to meet the applicable requirements and identify any need for updates, improvements or corrective action.

Manufacturer’s post-market surveillance system

Article 83 of the MDR requires the manufacturer to plan, establish, document, implement, maintain and update a post-market surveillance system for each device.

The system must be proportionate to the risk class of the device and appropriate for its type, intended purpose and characteristics.

In addition, the PMS system forms an integral part of the manufacturer’s quality management system.

For this reason, the information collected through post-market surveillance may contribute to updating the technical documentation and other related processes, such as risk management and clinical evaluation.

Post-market surveillance is therefore not an isolated activity. It is connected to the life cycle of the device and to the maintenance of information available after the device has been placed on the market.

What are post-market surveillance data used for?

The data collected through post-market surveillance may be used for several purposes.

In general terms, they may contribute to updating the benefit-risk evaluation, improving risk management, and updating design and manufacturing information, instructions for use and labelling.

They may also contribute to updating the clinical evaluation and, where applicable, the summary of safety and clinical performance.

PMS data may also help identify the need for preventive actions, corrective actions or field safety corrective actions, as well as highlight opportunities to improve the usability, performance and safety of the device.

Another relevant aspect is the identification of trends. Where the conditions provided for in the Regulation are met, certain trends may be subject to reporting under the applicable provisions.

Technical documentation must be updated accordingly when the information collected requires it.

The post-market surveillance plan

The PMS system is based on a post-market surveillance plan, or PMS plan.

For devices other than custom-made devices, the PMS plan is part of the technical documentation.

The PMS plan describes how the manufacturer intends to collect and use the information available after the device has been placed on the market. In general terms, it may indicate the sources considered, collection methods, data analysis methods, indicators, thresholds, responsibilities, frequencies and related processes.

The plan must be appropriate for the device or group of devices concerned. The planned activities should therefore be proportionate to the type of device, risk class, intended purpose and information available.

PMS plan may cover a single device or, where appropriate, a group of devices. In any case, the scope of the plan should be clear and consistent with the technical documentation.

What information may the PMS plan consider?

Annex III of the MDR describes the elements relating to the technical documentation on post-market surveillance.

In general terms, the PMS plan may consider different sources of information, including:

  • information concerning serious incidents and field safety corrective actions;
  • data on non-serious incidents and undesirable side-effects;
  • information from trend reports;
  • relevant specialist or technical literature;
  • relevant databases and registries;
  • complaints, comments and feedback from users, distributors and importers;
  • publicly available information about similar medical devices.

An important point is the proactive nature of post-market surveillance.

The manufacturer should not merely wait for reports or complaints. The PMS system must be organised to actively and systematically collect relevant information from post-market experience.

Sources and methods used must be assessed in the context of the device, its intended purpose, risk profile and the objectives of the PMS plan.

PMS report and PSUR

The results of post-market surveillance are documented through different reports, depending on the class of the device.

Under the MDR, the two main documents are the post-market surveillance report, or PMS report, and the periodic safety update report, or PSUR.

PMS report applies to class I devices.

The manufacturer of class I devices prepares a post-market surveillance report summarising the results and conclusions of the analysis of the data collected according to the PMS plan.

The report also includes a rationale and description of any preventive and corrective actions taken. It is updated when necessary and made available to the competent authority upon request.

The PSUR applies to class IIa, IIb and III devices.

The PSUR summarises the results and conclusions of the analyses of data collected as part of post-market surveillance, based on the PMS plan.

Throughout the lifetime of the device, the PSUR indicates, among other things, the conclusions to be used in the benefit-risk evaluation, the main findings of the PMCF, the sales volume of the device and an estimate of the size and characteristics of the population using the device, where applicable and where possible.

The PSUR also includes a rationale and description of any preventive and corrective actions taken.

In general terms, the PSUR should not be seen as a simple collection of data. It is a tool for periodically summarising and evaluating the information collected through post-market surveillance.

PSUR update frequency

The frequency of PSUR updates depends on the class of the device.

In the case of Class IIa devices, the PSUR is updated when necessary and at least every two years.

For class IIb and class III devices, the PSUR is updated at least once a year.

Regarding class III devices and implantable devices, the manufacturer submits the PSUR through the electronic system provided for by the MDR to the notified body involved in the conformity assessment.

For other devices, the PSUR is made available to the notified body involved in the conformity assessment and, upon request, to the competent authorities.

The operational arrangements may depend on the type of device, the applicable procedure and the functionalities made available by the relevant electronic systems.

Post-market surveillance and PMCF

In the MDR context, PMCF, or post-market clinical follow-up, is a continuous process connected to the clinical evaluation.

PMCF is addressed in the manufacturer’s post-market surveillance plan. It concerns the proactive collection and evaluation of clinical data relating to the use of the CE-marked device, placed on the market or put into service within its intended purpose.

In general terms, PMCF may contribute to confirming the safety and performance of the device throughout its expected lifetime, verifying the acceptability of the benefit-risk ratio, identifying emerging risks and detecting any systematic misuse or off-label use.

The PMCF plan specifies the methods and procedures for collecting and evaluating clinical data.

It may include, for example, the collection of clinical experience gained, user feedback, review of scientific literature, analysis of registries, PMCF studies, real-world evidence analyses or surveys addressed to healthcare professionals, patients or users.

The results of PMCF are analysed by the manufacturer and documented in a PMCF evaluation report.

This report becomes part of the clinical evaluation report and the technical documentation.

The conclusions of PMCF may have an impact on the clinical evaluation, risk management, the post-market surveillance plan and, where applicable, the summary of safety and clinical performance.

Post-market surveillance and vigilance

Post-market surveillance and vigilance are connected, but they are not the same thing because post-market surveillance concerns the systematic collection and analysis of data relating to the device after it has been placed on the market.

Vigilance, on the other hand, concerns in particular the reporting and management of serious incidents and field safety corrective actions under the applicable MDR provisions.

The data collected through the PMS system may help identify situations requiring further evaluation, preventive or corrective actions, or reporting under vigilance obligations.

For this reason, PMS and vigilance should be considered as connected areas within the manufacturer’s overall system, while maintaining distinct functions.

Why this guide does not define a PMS plan for specific cases

This guide does not define a PMS plan for specific devices and does not establish which activities, sources, frequencies, indicators or methods apply to a particular case.

The design of a PMS system depends on several elements, including the device’s intended purpose, the technology used, the risk class, the benefit-risk profile, the state of the art, the clinical data available, post-market experience, the involvement of the notified body and the applicable regulatory context.

For this reason, this page is descriptive in nature and refers to the official texts and reference documents.

Informational note

This guide is published for informational purposes only and does not constitute regulatory, legal, technical or professional advice.

The information is based on publicly available sources and was verified as of the date of publication or the latest update of this page. It may therefore not reflect subsequent changes or developments.

For assessments relating to specific cases, reference should be made to the official texts, the latest documentation issued by the competent authorities and, where appropriate, qualified professionals.

Official sources

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© Simone Ronco. Unless otherwise stated, the editorial content of this guide is an original work.

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