Updated July 2026
IVDR post-market surveillance is the system through which the manufacturer actively and systematically collects, records and analyses information on the in vitro diagnostic medical device after it has been placed on the market, also based on data and feedback from the operators involved.
This guide explains, for informational purposes, what Regulation (EU) 2017/746 provides in relation to post-market surveillance, what role is played by the PMS system, PMS plan, PMS report, PSUR and PMPF, and how these elements are connected to the life of the device on the market.
In the IVDR context, post-market surveillance is often referred to using the acronym PMS.
In this guide
- What does IVDR post-market surveillance mean?
- Manufacturer’s post-market surveillance system
- What are post-market surveillance data used for?
- The post-market surveillance plan
- What information may the PMS plan consider?
- PMS report and PSUR
- PSUR update frequency
- Post-market surveillance and PMPF
- Post-market surveillance and vigilance
What does IVDR post-market surveillance mean?
IVDR post-market surveillance refers to the activities carried out after an in vitro diagnostic 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 78 of the IVDR 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 performance 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 performance evaluation and, where applicable, the summary of safety and performance, or SSP.
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
PMS system is based on a post-market surveillance plan, or PMS plan.
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 IVDR 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 devices.
The PMS plan may also include references to processes related to communication with competent authorities, notified bodies, economic operators and users, where relevant.
An important point is the proactive nature of post-market surveillance.
Manufacturer should not merely wait for reports or complaints. The PMS system is designed to actively and systematically collect relevant information from post-market experience.
The 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 IVDR, 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 A and class B devices.
The manufacturer of class A and class B 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 notified body, where involved, and to the competent authority upon request.
The PSUR applies to class C and class D 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 of the benefit-risk evaluation, the main findings of the PMPF, the sales volume of the device and an estimate of the size and characteristics of the population using the device, where possible also with reference to frequency of use.
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.
For class C and class D devices, the PSUR is updated at least once a year.
For class D devices, the manufacturer submits the PSUR through the electronic system provided for by the IVDR to the notified body involved in the conformity assessment.
The notified body reviews the report and enters its evaluation into the electronic system, specifying any actions taken.
For class C 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 PMPF
In the IVDR context, PMPF, or post-market performance follow-up, is a continuous process connected to the performance evaluation.
PMPF is addressed in the manufacturer’s post-market surveillance plan. It concerns the proactive collection and evaluation of performance data and relevant scientific 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, PMPF may contribute to confirming the safety, performance and scientific validity of the device throughout its expected lifetime, verifying the acceptability of the benefit-risk ratio, identifying emerging risks and detecting any systematic misuse.
The PMPF plan specifies the methods and procedures for collecting and evaluating safety data, performance data and scientific data.
It may include, for example, the collection of clinical experience gained, user feedback, screening of scientific literature, analysis of registries, databases, epidemiological studies, post-market clinical performance studies, inter-laboratory tests or other quality assurance activities.
The results of PMPF are analysed by the manufacturer and documented in a PMPF evaluation report.
This report updates the performance evaluation report and becomes part of the technical documentation.
The conclusions of PMPF may have an impact on the performance evaluation, risk management and, where applicable, the summary of safety and performance.
Post-market surveillance and vigilance
Post-market surveillance and vigilance are connected, but they are not the same thing; 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 IVDR 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 performance 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 checked as of the publication or last update date of this page. It may therefore not reflect subsequent changes or developments.
For assessments relating to specific cases, it is necessary to refer to the official texts, the updated documentation of the competent authorities and, where appropriate, qualified professionals.
Official sources
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- MDCG 2025-10 — Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
Share this guide
If you find this guide useful, you can share it with other professionals interested in IVDR.
Want to stay updated on MDR and IVDR?
Subscribe to MDN – Medical Device News for free.
Subscribers receive the newsletter by email every Monday, one week before publication on the website.
Related resources
- What is the IVDR?
- IVDR Notified Bodies
- IVDR Codes
- IVDR Classification Rules
- IVDR Harmonised Standards
- UDI and Basic UDI-DI
Copyright and reuse
© Simone Ronco. Unless otherwise stated, the editorial content of this guide is an original work.
Short excerpts may be quoted with attribution to the author and a link to the original page.
Full reproduction, translation, adaptation or commercial use of the content requires prior written permission.