PMCF Surveys: How to implement them for your EU-MDR submissions
The EU Medical Device Regulation (EU MDR) is a new and updated set of regulations, following on from the Medical Device Directive (MDD), that will now come into force on May 26, 2021. It requires medical device manufacturers to take prime responsibility for getting their products CE-marked in order to sell in the European marketplace.
There is much more emphasis on a life-cycle approach to safety, backed up by clinical data and post-market monitoring. This will require manufacturers to not only reactively assess the safety and performance of their devices, but they will also need to proactively assess and record this data throughout the product’s lifecycle.
EU MDR's Post-Market Clinical Follow-up (PMCF)
“The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan”
In simple terms, PMCF falls within the Post-Market Surveillance (PMS) plan and will outline how the manufacturer will proactively collect and evaluate the clinical data from of their CE-marked medical device. The aims being described by the MDCG as:
Confirm the safety and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime.
Identify previously unknown side-effects and monitor the identified side-effects and contraindications.
Identify and analyse emergent risks on the basis of factual evidence.
Ensuring the continued acceptability of the benefit-risk ratio.
Identifying possible systematic misuse or off-label use of the device, with a view to verify that the intended purpose is correct.
PMCF via End-User Surveys
There are multiple options and strategies to consider when compiling the evidence for PMCF, with the main approaches being randomized clinical trials (RCTs), registry studies, retrospective patient record reviews, literature reviews, end-user surveys, and focus groups.
When weighing which approach(es) to take, it is vital that the balance between the level of evidence required and the time and effort to collect this evidence is considered. While RCTs and registries provide a higher level of evidence, they are often time consuming and expensive; end-user surveys, on the other hand, provide slightly lesser evidence but are much lower effort, cost-effective and have a much quicker turnaround.
The justification for end-user surveys will depend on the type of medical device, including the risk classification and previous data obtained. They can be used alongside other PMCF methods to strengthen the evidence of data for all risk classes, however, it would be recommended to perform a registry or study for any Class II/III devices without any previous clinical data.
How to implement PMCF End-User Surveys
Purdie Pascoe has conducted over 100 PMCF Surveys over the last couple of years for several of the leading medical device manufacturers, aiding them with both the design and the execution of the surveys themselves.
We have worked with clients who are at different stages of their PMCF process; some have their plans and surveys designed and ready to go but need help with the implementation, while others need help with the entire process from PMCF plan design through to reporting. At Purdie Pascoe, we can help with the below:
Determination of the appropriate approach, sample size and usage thresholds
Development / design of the PMCF plan
Development of the survey materials
Programming, testing and hosting of the online survey (in all local languages)
Recruitment of participants
Compensation of participants
Fieldwork management, coordination and quality control
Data processing
Analysis and interpretation of results
Delivery of raw data and a full PowerPoint/PDF report
Why Purdie Pascoe?
There are many reasons to use Purdie Pascoe to help implement your PMCF Surveys. With our experience in conducting over 100 PMCF surveys since January 2019, we are here to take the load off your backs, turning your PMCF plan into an online survey, managing the recruitment, collecting the data and turning this into visual and informative deliverables. Our approach is also compliant with both GDPR and Data Privacy regulations.
So make sure that you have everything in place to be compliant with the EU-MDR, today.
If you have any questions regarding this blog, or if you would like more information on how to develop successful delivery devices and beyond-the-pill solutions, please contact Marcus at marcus.torr@purdiepascoe.com