PMCF Surveys

There are many ways to collect these real-world post-market data, and it is vital to be able to justify which approach(es) is optimal for a given medical device. There are 2 aspects to consider:

clinical evidence requirements, i.e., clinical gaps identified in the CER and risk classification
feasibility of implementation, i.e., cost and timelines

PMCF Surveys offer a compliant, simple, timely and cost-effective means of RWD collection, especially for well-established technologies with lower risks of clinical gap exposure.

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 be scientifically justified, and the type of survey will depend on the type of medical device, including the risk classification and previous data obtained. Surveys can be used alongside other PMCF activities to strengthen pool of clinical evidence for all risk classes.

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

The survey method has been determined
Endpoints and eligibility criteria have been set based on identified clinical gaps
The sample size has been calculated statistically
The profile of the participants has been chosen based on the device’s nature
The questions address in a concise, short, intutive, structured manner all aspects of the device, i.e., frequency of use, clinical performance and safety, usability, claims by the manufacturer etc.

PMCF Survey: Steps Explained

Audit tested – compliant templates

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

Our PMCF Surveys Process a simplified approach

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

How Can Evnia help?

At Evnia, we support our partners throught the implementation of their PMCF strategies including the development and deployment of high-quality PMCF surveys. A cross-functional team conducts a gap assessment analysis to identify the optimal type of PMCF Survey and its respective objectives, prepares the PMCF survey protocol and the customized questionnaire, deploys the survey and analyzes the data.

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

Need more details?

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