PMPF plans and reports are essential elements of post-market surveillance (PMS) requirements for IVDs in the EU under IVDR. RQM+ provides comprehensive PMS services that include expert support for creating and maintaining PMPF documents so that they align with other relevant systems and PMS activities.
EU IVDR compliance requires that you submit a PMPF plan as part of your technical documentation to confirm the safety, performance, and scientific validity of your device. With former notified body leadership and a dedicated clinical and post-market surveillance team, we have the expertise to support you.
IVDR requires ongoing reporting and updates to documentation to demonstrate that your plan was followed. RQM+ can help you create systems to ensure that reports are updated efficiently so your PMPF documentation is always compliant.
When developing a PMPF plan, a key step is understanding what data must be captured and analyzed. We use our performance evidence matrix to highlight weaknesses and gaps to inform the strategy for telling the complete story.
If your notified body identifies nonconformities or gaps, RQM+ can help you achieve compliance and create a plan for addressing the nonconformities and maintaining your documentation. No matter what you need—strategy, PER, PMPF plan, or integration of it all—we have the expertise to guide.
Our clinical and post-market surveillance team is led by Amie Smirthwaite, PhD, former BSI global head of clinical compliance and contributor to “MDCG 2020-7, Post-Market Clinical Follow-Up (PMCF) Plan Template, A guide for manufacturers and notified bodies, April 2020.” While the PMPF guidance is still in process, it is expected to be similar to the PMCF guidance. Our MDCG committee experience, former NB leaders, IVD SMEs, and experience with IVDR implementations globally, provide us with unrivaled knowledge and expertise to meet your needs.
RQM+ develops PMPF plans that align with your performance evaluation reports (PERs) and strengthen areas of weakness in performance evidence. We also collaborate with you to develop plans that you can execute successfully.
Every PMPF project starts with a performance evidence matrix that compiles and stratifies available data to ensure indications and claims are supported as required by IVDR. Subject matter experts and medical writers with clinical and regulatory expertise collaborate to generate the matrix. The result is a document that clearly identifies shortcomings in performance evidence so you know what gaps need to be addressed.
All IVD manufacturers have different business goals and a mix of products to support them. Because there is no one-size-fits-all solution to PMPF planning and execution, RQM+ will identify multiple options and help you select the one that makes the most sense for your business priorities based on the associated risks.
In addition to providing an evaluation of the performance data for similar devices, guidance on methods, and rationale for the appropriateness of those methods, we will also reference the relevant parts of the PER and the risk management file to paint a complete picture for your notified body.
Writing a plan is just the beginning. You must also execute the plan and write reports that demonstrate your protocols are being followed. The expert implementers at RQM+ provide support by creating efficient systems and processes to keep the required resources and associated costs at a minimum without compromising on quality.
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ProceduresPMPF is new to many diagnostics manufacturers, which means new resources and additional costs. Let RQM+ experts implement procedures based upon best practices to optimize your resources and ensure implementation before your certification audit. |
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ProtocolsWithout protocols that are realistic and easy to follow, you’re setting yourself up to fail. Processes that are too cumbersome get abandoned, which means you fall out of compliance. RQM+ knows how to balance notified body expectations with the practical realities of execution. |
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Report WritingIVDR requirements include generating reports that evaluate the execution of your PMPF plans. This documentation must also align with other PMS and performance evaluation activities. RQM+ understands the big picture and knows how to effectively communicate it to notified bodies. |
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Report MaintenancePMPF is a continuous process that requires ongoing planning and reporting as new information becomes available. RQM+ can create and maintain a reporting schedule so your team can focus on daily operations without worrying about PMPF compliance. |
PMPF is just one page in the PMS story.
The best way to tackle any component of post-market surveillance is to do it with the whole story in mind because this is how notified bodies approach it. If your documents don’t align, it leads to reviewer questions and a longer approval process. Our integrated approach ensures your PMS activities and documentation always align.
Learn about Post-Market Clinical Follow-up
Learn about Quality System Integration
Learn about Retrospective PMCF/PMPF Study Development and Execution
In short, no because that is not the purpose of PMCF because you need to demonstrate conformity. Often, you do have gaps in your clinical data. You might have a lot of data on one indication and less on another one, but you can’t pose it as a gap and that you don’t have sufficient clinical evidence to demonstrate safety and performance for that indication.
We have seen the gamut from lower risk to higher risk devices needing PMCF. For example, we had a pretty well-established Class IIa device that had limited clinical data that was not high quality. They used equivalence and then got a finding asking them to prove they had sufficient clinical evidence for initial conformity based on the studies they did have.
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