PMCF Surveys

PMCF Surveys are a step-wise, cost-saving PMCF activity with quick turnaround times that can deliver answers for clinical gaps identified in your clinical evaluation report

PMCF surveys must always be scientifically justified to be used alongside other PMCF activities to strengthen pool of clinical evidence for all risk classes.

Whether an HCP or end-user/patient survey, high quality data may be collected provided that

The type of Survey has been chosen based on data collection needs
Endpoints and eligibility criteria have been set to account for clinical gaps
The sample size has been calculated based on a statistical plan
The profile of the participants has been chosen based on the device’s nature and history
The questions address in a concise, short, intuitive, structured manner the device’s clinical performance and safety, usability, claims etc.

Level 4 vs. Level 8 PMCF Surveys

In the rapidly evolving landscape of MedTech, PMCF surveys have become a useful post-market tool for the collection of clinical data.

According to the Guidance MDCG 2020-6, different data collection methods provide data with different levels of evidence.

Results of high quality clinical investigations covering all device variants, indications, patient populations, duration of treatment effect, etc.

Results of high quality clinical investigations with some gaps

Outcomes from high quality clinical data collection systems such as registries

Outcomes from studies with potential methodological flaws but where data can still be quantified and acceptability justified, e.g., high-quality surveys

Equivalence data (reliable / quantifiable) BUT equivalence must be established as per EU-MDR criteria

Evaluation of state of the art, including evaluation of clinical data from similar devices as defined in Section 1.2 of MDCG 2020-06

Complaints and vigilance data; curated data Note: not generally considered a high-quality source of data due to limitations in reporting. It may be useful for identifying safety trends or performance issues.

Proactive PMS data, such as that derived from surveys

Individual case reports on the subject device

Compliance to non-clinical elements of common specifications considered relevant to device safety and performance

Simulated use / animal / cadaveric testing involving healthcare professionals or other end users Note: particularly in terms of usability, such as for accessories or instruments.

Pre-clinical and bench testing / compliance to standards

Interestingly, PMCF Surveys are assigned both an evidence level of 4 and a lower evidence level of 8.

PMCF surveys are categorized into general surveys (level 8) and high-quality surveys (level 4). The difference between them is substantial.

Level 8 general surveys are intended to collect general data, typically based on a clinician’s memory/experience.
Level 4 high-quality surveys are intended to collect specific data triggered by specific gaps in the clinical performance and safety of a medical device. Usually, they are based on the retrospective analysis of patient data.

PMCF Survey: Steps Explained

Audit tested – compliant templates

Cross-functional team of medical writers, biostatisticians, clinicians and researchers

When to implement a high-quality (level 4) vs. a general (level 8) PMCF Survey?

Given that class III and implantable legacy devices are expected to have sufficient clinical evidence at a minimum of level 4 per MDCG 2020-6 hierarchy, are high-quality surveys a relatively easy and cost-efficient option for the collection of post-market clinical data to support a device’s clinical performance and safety?

The short answer is that it depends on the nature and complexity of the data that must be collected and the readiness status in terms of GDPR-compliant processes.

A level 4 PMCF Survey must always comply with GDPR requirements and may additionally require approval from an Ethics Committee. The golden rule is that, if a survey collects data about the device user (healthcare provider) but not patient-specific data or patient-identifying information, an approval from the Ethics Committee is not required.

The level of post-market evidence required for a medical device depends, among others, on

the risk classification of the device,
the pool of available evidence,
the continuous acceptability of the benefit-risk profile and
the time spent on the market

Overall, level 4 PMCF surveys should be preferred for higher risk devices or devices with limited available evidence either due to shorter time on the market or because of the lack of device-specific clinical data. Although clinical investigations will provide the highest level of evidence, a high-quality (level 4) PMCF survey can also support answers to clinical gaps especially when the latter have been concretely identified in the CER. A high-quality PMCF survey enables the evaluation of potential systematic misuse and off-label usage, which may not be possible to identify within the context of a clinical investigation due to the stringency of eligibility criteria.

However, it should be clear that a level 4 PMCF Survey has increased requirements and requires rigorous planning for the determination of endpoints, acceptance criteria and statistical justification of the sample size. A justification on the appropriateness of the level 4 PMCF Survey to generate sufficient evidence is required. This justification should take into account the specific needs that have led to its conduct, e.g., as an output of the clinical evaluation report, PMS, risk management report, previous PMCF report, to address nonconformities raised by a Notified Body, etc. Although there is flexibility to collect either retrospective or prospective data, the associated fieldwork timeframes and costs are higher, while the State of the Art and potential comparators must be taken into account.

Evnia’s Level 4 PMCF Survey Process: A simplified outline

Link to PMCF & Identify Objectives

Identify clinical gaps in previous CER

Review Technical Documentation to

- Identify clinical claims made by the manufacturer
- Define outcomes to measure

Generate a PMCF Survey Protocol

Rationale/Objectives

Calculation and justification of sample size

Identification of target population

Ensuring full access to the contact details of end-users, i.e., optimize loop of communication with EOs

Justification of survey’s timeline

Finalization of questionnaire

Validation

Address potential ethical considerations and/or GPDR issues

Outline of the methods for the analysis of collected data

Deploy the PMCF Survey

Collection of data via a validated tool

Engage with end-users to maximize participation, i.e., explain the importance of the proactive collection of real-world clinical data and their impact for the uninterrupted supply of the market with MDs

Report AEs, SAEs immediately based on the regional regulatory framework and the manufacturer’s QMS

Collect and Analyze Data

Lock the survey

Clean/Analyse/Interpret the data

Write the PMCF Survey Report and

- Decide whether additional PMCF activities are required
- Evaluate the acceptability of the benefit-risk ratio

Feed into the PMCF Report, the CER, PSUR, RM and Technical Documentation

On the other hand, level 8 PMCF Surveys are more straight-forward, faster in terms of deployment and less stringent from a regulatory perspective. A level 8 PMCF Survey may be completed based across multiple retrospective usages and the relevant questions are targeting the general aspects of the device’s uses. The justification that the generated/collected data will be sufficient for the device in question is even more relevant in this case as the approach will, by definition, result in lower level of evidence.

Design of the questionnaire

Keep it short: No more than 5 minutes for level 8 / up to 10 minutes for level 4 PMCF Surveys.
Use questions that can be answered with Yes/No, scoring systems (e.g. rating on a scale of 1-5), or selection of checkboxes.
Try to avoid open text fields to maximize participation.
Ask questions applicable to the device and the survey respondent. Be specific. Take into consideration regional differences in the usage of the device.
Follow a narrative. Send out a structured questionnaire that includes questions about frequency of use, general user, device use, intended procedure, clinical performance and safety.
Include questions to help identify previously unknown side-effects and emergent risks, as well as possible systematic misuse or off-label use of the device.

Common PMCF Surveys Pitfalls

Poor study design
Lack of statistical considerations (insufficient sample size or lack of statistical justification)
Lack of device-specific endpoints; questions; objectives

How Can Evnia help?

At Evnia, we support our partners through the implementation of their PMCF strategies including the development and deployment of both general and high-quality PMCF surveys.

A cross-functional team conducts a gap assessment to identify clinical gaps, the patient chart and the use of the medical device in the clinical practice. The decision for the optimal type of PMCF Survey is based on evidence from the clinical evaluation, risk management, post-market surveillance (including vigilance) of the target device. The respective objectives, preparation of the PMCF survey protocol and customized questionnaire, deployment of the survey and data analysis is part of a dynamic interaction between Evnia’s team and the manufacturer.

We harness digital platforms to streamline data collection:

Being the Strategic Alliance Partner of Smart-Trial by GreenLight Guru, we ensure:

Deployment of the survey in a pre-validated data platform, compliant with ISO 14155:2020 requirements
Fully documented data traceability
GDPR compliance
Facilitation of real-time data entry and access
Reduced likelihood of errors and improvement of the quality of the collected data
Simplification of survey deployment
Enhanced participant compliance through user-friendly interfaces and accessible formats

At Evnia, we leverage all data sources after critical appraisal. PMCF Surveys have a strategic added value for Post-Market Surveillance. Contact Evnia today to help you identify the optimal PMCF Activity for your portfolio!

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