PMCF Clinical Trials: Definition, Requirements and Clinical Data Collection

Under the European Medical Device Regulation (EU) 2017/745 (MDR), Post-Market Clinical Follow-up (PMCF) is a continuous process that updates the clinical evaluation and forms part of the manufacturer's post-market surveillance system.

Its purpose is to continuously collect and evaluate clinical data throughout the lifecycle of a medical device to confirm its safety and performance, monitor known risks, and identify potential emerging risks.



But what exactly are the PMCF requirements? Is a new clinical trial always required? What clinical data should medical device manufacturers collect, and how should this data collection be organized?

What Is PMCF?

PMCF is the clinical component of a medical device manufacturer's post-market surveillance activities.Under Part B of Annex XIV of the MDR, manufacturers must proactively collect and evaluate clinical data from the use in or on humans of a CE-marked medical device that is placed on the market or put into service within its intended purpose.

PMCF is designed to:

• confirm the safety and performance of the medical device throughout its expected lifetime;
• identify previously unknown side effects and monitor identified side effects and contraindications;
• identify and analyze emerging risks based on factual evidence;
• ensure the continued acceptability of the benefit-risk ratio;
• identify possible systematic misuse or off-label use of the device.

PMCF should not be viewed simply as a clinical trial conducted after market access. It is a continuous process that helps keep the clinical evaluation up to date throughout the lifecycle of the medical device.

PMCF, PMS and Clinical Evaluation: What Is the Difference?

These concepts are closely connected, but they are not interchangeable.

Post-Market Surveillance (PMS) is the broader system through which manufacturers collect and analyze information relating to the quality, performance, and safety of a medical device after it has been placed on the market.

PMCF is part of PMS and focuses specifically on the proactive collection and evaluation of clinical data from the use of the device after it has been placed on the market.

The clinical evaluation brings together and assesses the clinical evidence used to demonstrate the safety, clinical performance, and clinical benefits of the medical device. Under the MDR, the clinical evaluation must be updated throughout the device lifecycle using relevant post-market data, including data obtained through PMCF.

The relationship can therefore be summarized as:

Is PMCF Mandatory?

This is one of the most important distinctions to understand. The MDR gives PMCF a central role in the post-market clinical monitoring of medical devices and requires manufacturers to establish a strategy appropriate to their device.



However, this does not mean that every medical device must automatically be subject to a new PMCF clinical trial. The MDR provides for different methods of collecting and evaluating clinical data. Where PMCF is not considered applicable, the manufacturer must provide a justification.

Two common shortcuts should therefore be avoided:

• “Every medical device requires a new PMCF clinical trial.”: No.
• “PMCF is optional.”: Also misleading.

The manufacturer needs to determine, document, and justify the appropriate PMCF strategy based on the medical device and the remaining clinical questions that need to be addressed.

What Is a PMCF Plan?

The PMCF Plan describes how the manufacturer intends to collect and evaluate additional clinical data after the medical device has been placed on the market.

Under the MDR, the plan should define the methods and procedures used to confirm safety and performance throughout the expected lifetime of the device, monitor identified side effects and contraindications, identify emerging risks, and ensure the continued acceptability of the benefit-risk ratio.

The European Commission has also published MDCG 2020-7, which provides a dedicated template for structuring a PMCF Plan.

A PMCF Plan should therefore do more than state that a study or clinical trial will be conducted. It should establish which clinical questions need to be addressed and which methods are appropriate to answer them.

Is a PMCF Clinical Trial Always Necessary?

No. This distinction is essential.



PMCF is a continuous clinical data generation and evaluation strategy, whereas a PMCF study or clinical trial is one of the methods that may be used as part of that strategy.

Annex XIV of the MDR provides for general and specific methods and procedures to proactively collect and evaluate the necessary clinical data.

Depending on the medical device and the remaining clinical questions, the PMCF strategy may use clinical experience, scientific literature, registries, real-world clinical data, surveys, or dedicated PMCF studies and clinical trials.

The choice of method should therefore begin with the clinical question the manufacturer needs to answer, rather than with the assumption that a new clinical trial must automatically be conducted.

What Types of Clinical Trials and Data Can Be Used for PMCF?

When additional clinical data collection is required, the study or clinical trial design should follow from its clinical objectives.

A prospective clinical trial or study makes it possible to define the clinical data to be collected, visits, endpoints, and follow-up duration in advance. This approach can be particularly appropriate when new, structured clinical data are required.

A retrospective study can use clinical data that are already available in medical records. This may allow certain questions to be addressed more rapidly, but the availability and quality of existing data should be assessed before defining the variables and statistical analyses.

A clinical registry can be particularly valuable for medical devices that require several years of follow-up. It can progressively build a clinical database documenting device safety and performance in real-world clinical practice.

PMCF strategies may also use Real-World Data (RWD) to generate Real-World Evidence (RWE).

What Role Can Registries and Real-World Data (RWD/RWE) Play?

Registries and real-world data can help document the safety and performance of medical devices after they have been placed on the market, particularly over longer follow-up periods.

A systematic review of 145 publications using RWD/RWE for post-market medical device evaluation found that these data are already being used to assess medical devices under real-world conditions and document medium- and long-term outcomes. Their value, however, depends on data quality and traceability.

The same applies to medical device registries. Recent research highlights the importance of data completeness, clearly defined outcomes, and the quality of statistical analyses in generating usable clinical evidence.

For PMCF, the objective is not simply to collect more data, but to obtain sufficiently complete, reliable, and relevant data to answer the clinical question.

What Clinical Data Should Be Collected in a PMCF Clinical Trial?

There is no universal list of variables that applies to every medical device. The data to be collected should derive from the PMCF objectives, identified risks, the intended purpose and characteristics of the medical device, and the endpoints defined in the clinical trial protocol.

Depending on the study and the clinical questions being addressed, the data may, for example, include relevant patient characteristics and risk factors, use of the medical device and the associated procedure, clinical performance and benefits, complications and adverse events, Patient-Reported Outcomes, imaging data, or data collected during follow-up visits. Other data may be required depending on the medical device and the clinical questions being investigated.

The objective is not to maximize the number of variables collected, but to collect the data needed to answer the clinical questions defined before the study begins.

How Should Clinical Data Collection Be Organized for a PMCF Clinical Trial?

Effective clinical data collection begins before the first form is created.

The objectives, endpoints, patient population, visit schedule, and planned analyses should be defined in advance. These elements then determine which variables actually need to be collected.

The Case Report Form (CRF), or its electronic version, the eCRF, translates the clinical trial protocol into structured clinical data.

EDC/eCRF software can be used to centralize data collected by multiple investigators or clinical sites, structure clinical variables, implement data consistency checks, monitor data completeness, and prepare the database for monitoring and statistical analysis.

The MDR does not prescribe a specific EDC software solution. The objective is to generate sufficiently reliable and usable clinical data to meet the objectives of the clinical trial and the applicable requirements.

The way the eCRF is designed therefore deserves particular attention. For a detailed methodology, see our guide “PMCF Clinical Trials: How to Design an Effective eCRF.”

When Does a PMCF Study Become a Clinical Investigation Under the MDR?

Not all PMCF activities follow the same regulatory pathway.



The applicable requirements depend on factors such as how the medical device is used, whether it is used within its intended purpose, and whether additional procedures are imposed on study participants.

Article 74 of the MDR contains specific provisions for certain post-market clinical investigations involving CE-marked devices used within their intended purpose.

Different requirements may apply when a medical device is investigated outside its intended purpose.

The regulatory qualification of the project should therefore be determined before the clinical trial or investigation begins, based on the protocol and the actual conditions under which the device will be used.

For PMCF projects involving a clinical investigation, manufacturers should assess the applicable MDR provisions and relevant MDCG guidance rather than assuming that every PMCF data collection activity qualifies as a clinical investigation.

What Is a PMCF Evaluation Report?

Clinical data collected through PMCF activities must subsequently be evaluated.

The results are documented in the PMCF Evaluation Report (PMCFER) and contribute to updating the clinical evaluation and, where appropriate, other elements of the medical device technical documentation. Annex XIV of the MDR explicitly establishes this relationship between PMCF results and the clinical evaluation.

The European Commission has published MDCG 2020-8, which provides a dedicated template for the PMCF Evaluation Report.

MDCG 2020-8: PMCF Evaluation Report Template

The PMCF process can therefore be viewed as a continuous loop:

How Are PMCF and the PSUR Connected?

PMCF also forms part of the broader post-market surveillance system.

For medical devices subject to a Periodic Safety Update Report (PSUR), the MDR requires the PSUR to include, among other information, the main findings of PMCF and the conclusions of the benefit-risk determination.

For Class IIb and Class III medical devices, the PSUR must generally be updated at least annually. For Class IIa devices, it must be updated when necessary and at least every two years.

PMCF, clinical evaluation, risk management, and PMS should therefore not be treated as independent documentation exercises.

They are interconnected components of the medical device's post-market lifecycle.

Which Software Should You Use to Collect Data for a PMCF Clinical Trial?

When a PMCF clinical trial involves multiple investigators or clinical sites, EDC/eCRF software can help centralize and structure clinical data, implement consistency checks, monitor data completeness, and prepare the data for monitoring and statistical analysis.

To learn more, discover how to choose the right EDC/eCRF software for a PMCF clinical trial.

PMCF Is a Continuous Process, Not an Isolated Clinical Trial

PMCF does not begin with the selection of EDC software and does not end when the last patient completes the final clinical trial visit.

It is a continuous process of collecting and evaluating clinical data that accompanies a medical device after it has been placed on the market. This lifecycle approach is explicitly established in Annex XIV of the MDR.

Manufacturers should first determine which clinical questions remain unanswered and then select the methods best suited to address them, whether through scientific literature, existing clinical data, registries, real-world data, or dedicated PMCF clinical trials.

When new clinical data need to be collected directly from investigators or patients, the quality of the clinical trial protocol, CRF/eCRF design, and data collection process becomes critical.



The objective of PMCF therefore extends beyond producing regulatory documentation. It is about maintaining an up-to-date clinical evaluation supported by relevant clinical data throughout the lifecycle of the medical device.