Post-market surveillance (PMS) is a systematic, proactive and continuous process for collecting, analyzing and assessing information about a medical device after it has been placed on the market. It serves to monitor the safety, performance and benefit-risk ratio of the product throughout its entire lifecycle. In the US, “postmarket surveillance” additionally has a narrower meaning: studies ordered by the FDA under Section 522 (see regulatory reference below).
Among other things, new hazards, changed risks, technical problems, use errors, difficulties with the user interface and previously unconsidered use situations can be detected. The results of post-market surveillance feed, among other things, into risk management, clinical evaluation, usability engineering, product development and quality management. If necessary, manufacturers must initiate suitable preventive or corrective actions.
- Post-market surveillance as a source of information for human factors engineering
- Relevant data sources
- Link to the use-related risk analysis
- Post-market surveillance and usability evaluation
- Delimitation from vigilance and post-market clinical follow-up (PMCF)
- Typical weaknesses in practice
- Regulatory reference
- Frequently asked questions (FAQ)
Post-market surveillance as a source of information for human factors engineering
In human factors engineering, the consideration of use-related risks does not end with the summative evaluation or human factors validation. Development-accompanying and summative evaluations are carried out with a limited number of representative users, tasks and conditions of use. They therefore cannot depict all situations that occur during the long-term use of a medical device on the market.
Post-market surveillance data provide information on how products are used under real conditions of use and which use problems occur despite careful development and evaluation. From a human factors perspective, the following observations are particularly relevant:
- Use errors and close calls
- Misunderstandings and misinterpretations
- Difficulties in recognizing system states
- Problems with alarms, displays or controls
- Mix-ups of products, connectors or functions
- Difficulties with instructions for use and labeling
- Deviations from intended workflows
- Unexpected or changed contexts of use
- Difficulties with cleaning, reprocessing, maintenance or installation
- Recurring training and support requests
- Use by user groups not intended
Such insights make it possible to check the original assumptions from the use specification, the context analysis, the task analysis and the use-related risk analysis and to update them if necessary.
PMS should not be directed only at harm that has already occurred. Use difficulties, close calls and recurring support questions can also provide early indications of weaknesses in the user interface or of insufficiently controlled use risks. The FDA explicitly emphasizes that reports on use errors and close calls can provide important information on underlying design and context factors.
Relevant data sources
Post-market surveillance comprises significantly more than processing complaints or evaluating reportable incidents. Depending on the product, its risk class and its context of use, the following information sources in particular can be relevant:
- Customer complaints
- Vigilance reports and serious incidents
- Trend reports
- Service data and repair reports
- Returns and failure analyses
- Training feedback
- Support requests and helpdesk data
- User surveys and customer feedback
- Post-market clinical follow-up
- Scientific and technical literature
- Registry and study data
- Data on comparable products
- Information from authorities and notified bodies (the EU conformity assessment bodies)
- Recalls and safety information of other manufacturers
- Feedback from sales and application support
- Information from distributors and importers
- Internal quality data
- Findings from CAPA processes
For software and digital medical devices, the following sources can additionally be considered:
- Support tickets
- Error messages and log data
- Abandonment rates in use processes
- Recurring navigation problems
- Tasks not completed successfully
- Technical telemetry
- Cybersecurity vulnerabilities
- Data on versions, configurations and updates
The use of usage or telemetry data must take place taking into account data protection, IT security and consent or legal bases.
For the US market, the MAUDE database, medical device reports, recall information and FDA safety communications, among others, can be relevant external sources of information. Data from MAUDE and comparable reporting systems must, however, be interpreted carefully. A report does not automatically prove that the product caused the event. Because of possible underreporting, incomplete information and missing reference values, reliable event rates generally cannot be derived from passive reporting data.
There are also publicly accessible sources for the European area. The Federal Institute for Drugs and Medical Devices (BfArM) publishes field safety notices (FSN) on safety corrective actions by manufacturers in Germany. The Swiss Agency for Therapeutic Products Swissmedic maintains a corresponding list for Switzerland and Liechtenstein, and the British authority MHRA (Medicines and Healthcare products Regulatory Agency) publishes field safety notices and further safety information on medical devices. At EU level, a module for vigilance and post-market surveillance is planned in the European database on medical devices EUDAMED, which according to the European Commission is still under development (as of October 2026).
These sources can so far be analyzed for use-related events in a targeted way only to a limited extent. The publications can be searched, for example, by product group, type of report or period, but there is no separate category for use errors or usability problems. Whether an event is related to use must therefore be inferred in each case from the text of the notice. Nevertheless, these sources belong in post-market surveillance, and with the further expansion of EUDAMED their importance is likely to increase.
The quality of post-market surveillance does not depend on the number of data sources alone. What matters is whether the information is brought together systematically, assessed and translated into suitable decisions.
Link to the use-related risk analysis
Post-market surveillance is a central input for the continuous updating of risk management and the use-related risk analysis. PMS data can show that:
- Previously unidentified use errors occur
- Known use errors occur more frequently than assumed
- Effects are more serious than originally assessed
- New user groups or contexts of use become relevant
- Existing risk control measures are not sufficiently effective
- Users do not take warnings or instructions for use into account as expected
- Foreseeable misuse has so far not been taken into account appropriately
- The generally recognized state of the art has changed.
Recurring misuse should not be hastily classified as individual misbehavior of users. It must be examined whether characteristics of the user interface, organizational conditions, training concepts or contexts of use contribute to the problem. If new or changed use-related risks arise, manufacturers must check whether additional measures are required. These can include:
- Design changes to the user interface
- Changes to the operating logic
- Additional plausibility checks
- Improved system feedback
- Revision of alarms and warnings
- Changes to labeling or instructions for use
- Adjustment of training and support measures
- Extension of post-market surveillance
- Carrying out additional formative evaluations
- Renewed verification or validation of the changes concerned
- CAPA or field safety corrective actions
The selection of measures should follow the established regulatory priority: Risks should first be reduced as far as possible by inherently safe design. Protective measures as well as safety information and training are then to be considered according to their suitability.
Post-market surveillance and usability evaluation
Post-market surveillance and usability evaluation pursue different but interconnected goals. A formative evaluation is used during development to detect weaknesses of the user interface and to improve the design. The summative evaluation or human factors validation examines whether the intended users can cope safely with the selected hazard-related use scenarios using the final user interface under representative conditions.
Post-market surveillance starts after placing on the market and examines the actual use of the product over a longer period and in a greater variety of real use situations. Post-market surveillance data therefore replace neither formative nor summative evaluations. Conversely, a successfully completed human factors validation does not end the obligation to monitor use-related problems on the market systematically.
PMS data can mean that additional usability activities become necessary, for example:
- Interviews with affected users
- Observations in the real context of use
- In-depth task or workflow analyses
- Root cause analyses
- Expert reviews of the user interface
- Formative evaluations of design changes
- Comparative usability tests
- Renewed summative evaluations after significant changes
Not every single piece of market feedback automatically requires a new usability evaluation. Manufacturers must, however, assess in a comprehensible way whether the signal is safety-relevant, whether there is a systematic problem and whether the existing evidence is still sufficient.
Delimitation from vigilance and post-market clinical follow-up (PMCF)
Post-market surveillance, vigilance and post-market clinical follow-up are closely connected but not synonymous. Post-market surveillance denotes the overarching system for the systematic and proactive collection, analysis and assessment of information about a product after it has been placed on the market.
Vigilance comprises in particular the regulatory assessment and reporting of serious incidents as well as the implementation and communication of field safety corrective actions. Trend reporting concerns the statistically significant increase in the frequency or severity of certain non-serious incidents or expected undesirable side effects where this can influence the benefit-risk assessment.
Post-market clinical follow-up (PMCF) is a continuous process for updating the clinical evaluation of a medical device that already bears the CE mark. PMCF collects and assesses in particular clinical data from actual use. PMCF is thus a component of post-market surveillance but does not replace the entire PMS system. Likewise, vigilance is only one sub-area of post-market activities. For IVDs, the corresponding term is post-market performance follow-up (PMPF).
| Term | Comprises |
|---|---|
| Post-market surveillance (PMS) | The overarching system for the systematic and proactive collection, analysis and assessment of information about a product after it has been placed on the market |
| Vigilance | In particular the regulatory assessment and reporting of serious incidents as well as the implementation and communication of field safety corrective actions. Only a sub-area of post-market activities |
| Trend reporting | The statistically significant increase in the frequency or severity of certain non-serious incidents or expected undesirable side effects where this can influence the benefit-risk assessment |
| Post-market clinical follow-up (PMCF) | A continuous process for updating the clinical evaluation of a medical device that already bears the CE mark. A component of post-market surveillance, does not replace the entire PMS system. For IVDs: post-market performance follow-up (PMPF) |
Typical weaknesses in practice
A frequent problem is to reduce post-market surveillance to processing incoming complaints. A PMS system must, however, determine proactively which information is needed, from which sources it comes, how often it is collected and according to which criteria it is evaluated. Current MDCG guidance emphasizes in particular the definition of suitable data sources, methods, indicators and thresholds. Further typical weaknesses are:
- Exclusively reactive data collection
- Missing human factors categories in complaint and service data
- Insufficient capture of use errors and close calls
- Inconsistent terminology
- Missing or unsuitable search terms for literature and database searches
- Missing consolidation of different data sources
- Missing reference values such as sales figures or usage frequencies
- No defined indicators and thresholds
- Missing trend analyses
- Unclear responsibilities
- Insufficient involvement of human factors and usability engineering
- Insufficient root cause analyses
- Hasty classification of problems as “user error”
- Missing feedback into risk management and clinical evaluation
- Missing assessment of the effects on the use specification and user profiles
- No comprehensible decision on necessary measures
- Missing verification of the effectiveness of implemented measures
A further weakness is to search exclusively for problems that are already known. An effective PMS system must also be suitable for detecting previously unknown hazards, changed usage patterns and new combinations of contributing factors.
Regulatory reference
Regulation (EU) 2017/745 (MDR) requires manufacturers to plan, establish, document, apply, maintain and update a PMS system appropriate to the risk class and type of the device. The central requirements are found in particular in Article 83 (post-market surveillance system), Article 84 (PMS plan), Article 85 (PMS report), Article 86 (periodic safety update report), Articles 87 to 92 (vigilance and trend reporting), Annex III (technical documentation on post-market surveillance) and Annex XIV Part B (PMCF).
MDCG guidance specifies the requirements for PMS systems for medical devices and in vitro diagnostic devices. Among other things, it describes the selection of suitable information sources, data collection and analysis, drawing conclusions and the link of the PMS system with other processes of the quality management system. Such guidance is not legally binding but provides important orientation for regulatory implementation.
For class I medical devices, a post-market surveillance report according to Article 85 is generally drawn up and updated where necessary. For products of classes IIa, IIb and III, a periodic safety update report (PSUR) is required according to Article 86. The PSUR summarizes results and conclusions from the activities defined in the PMS plan and deals in particular with the benefit-risk assessment, essential results from PMCF and, where applicable, preventive and corrective actions taken.
Regulation (EU) 2017/746 (IVDR) also requires a systematic PMS system for in vitro diagnostic devices. The basic approach corresponds to the MDR but takes into account the particular requirements for performance, scientific validity and post-market performance follow-up.
ISO 14971 requires the systematic collection and evaluation of information from production and from downstream phases. Relevant findings must be checked as to whether previously unknown hazards exist, risks are no longer acceptable or the generally recognized state of the art has changed.
In the US context, various postmarket requirements exist, including medical device reporting, recall and correction processes and, where applicable, postmarket surveillance studies ordered by the FDA under Section 522 and 21 CFR Part 822. These ordered studies are not directly equivalent to the general European PMS system.
Post-market surveillance is a systematic, proactive and continuous process for monitoring the safety and performance of a medical device after it has been placed on the market. From a human factors perspective, it provides important insights into how products are used under real conditions and which use problems occur outside controlled evaluations.
An effective PMS system connects: market data → signal detection → assessment → risk management → measures → verification of effectiveness. Post-market surveillance is thus not an isolated report and not mere complaint handling but a continuous learning and decision process.
Frequently asked questions (FAQ)
Does post-market surveillance begin only after placing on the market?
The operational collection of market data begins with placing on the market or the actual use of the product. The PMS system and the PMS plan must, however, be defined already before placing on the market, including information sources, methods, responsibilities, evaluation intervals, indicators and thresholds.
Is processing complaints already a PMS system?
No. Complaints are merely one possible data source of the PMS system. A regulatory-robust PMS system must take different reactive and proactive data sources into account, assess the information systematically and feed the results back into other relevant processes of the quality management system.
Does every use problem have to be reported to the authority?
No. Not every use problem meets the criteria of a reportable serious incident. Every relevant problem must, however, be recorded and assessed internally. It must be checked whether reporting obligations, trend reporting, CAPA, changes to risk management or other measures are required.
Is PMCF the same as PMS?
No. PMCF is a component of the PMS system and concentrates on the continuous collection and assessment of clinical data. The PMS system also comprises, for example, complaints, vigilance data, technical information, service data, literature, trend analyses and information on use problems.
Can PMS data make a new usability evaluation necessary?
Yes. If PMS data point to new or changed use risks, systematic use problems or insufficient risk control measures, additional formative or summative evaluations can become necessary. Whether and to what extent an evaluation is necessary depends on the cause, the possible harm, the affected design change and the evidence already available.
How should use errors be recorded in PMS data?
Use errors should be documented as concretely and context-related as possible. This includes in particular the user group concerned, the task performed, use situation and environmental conditions, expected and actual behavior, the state of the product, perceived information, decision and action of the user, the system response, possible or actual effects, contributing factors and existing training and experience. A mere classification as “user error” is generally not sufficient for a robust root cause analysis.
Do you want to integrate use-related insights systematically into your PMS system and derive robust measures for risk management and product development from them? We support you in analyzing market data, use errors and contexts of use and in carrying out suitable human factors activities.
More about our usability engineeringSources
- ISO 14971:2019, Medical devices, Application of risk management to medical devices
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- 21 CFR Part 822, Postmarket Surveillance
- FDA MAUDE, Manufacturer and User Facility Device Experience Database
- EUDAMED, European Database on Medical Devices