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Post-Market Clinical Follow-up (PMCF) is no longer optional. Under the EU Medical Device Regulation (MDR), it’s a mandatory part of your post-market surveillance strategy, and a critical piece of your technical documentation.
But PMCF isn’t just about executing clinical activities. It’s about producing clear, consistent, and audit-ready documentation that ties together your regulatory strategy, clinical evaluation, and post-market evidence. That’s where expert medical writing comes in.
In this blog, we explore how QbD helps medical device manufacturers meet MDR requirements with strong PMCF planning, documentation, and execution, from initial justification to final report.
PMCF Under MDR: Where Regulation Meets Documentation
PMCF is part of the broader Post-Market Surveillance (PMS) system and applies to all CE-marked medical devices, whether new or legacy. Its purpose? To proactively confirm the safety and performance of your device in real-world use, identify emerging risks or patterns of misuse, and continuously feed evidence back into your technical documentation.
Regulators expect to see:
And all of it must be supported by clear, scientifically robust documentation, compliant with MDR and relevant guidance documents.
Why Expertise Is Critical to PMCF Success
Having good data is not enough; how you present that data is just as important. At QbD Group, our medical writers specialize in MDR-compliant clinical documentation. We help you:
This isn’t just templating—it’s medical writing that bridges evidence, interpretation, and regulatory logic, designed to withstand Notified Body scrutiny.
How QbD Supports PMCF: From Strategy to Submission
We offer an integrated clinical and regulatory approach to PMCF. Whether you need strategic input, documentation, or study execution, our team is ready to assist.
Our services include:
Together, we help you build a PMCF system that supports regulatory compliance, product improvement, and continued market success.
Conclusion: A Solid Strategy Is the Key to PMCF Compliance
Complying with MDR goes beyond ticking boxes. It requires well-executed activities and high-quality documentation that demonstrates your device’s real-world performance and safety.
At QbD Group, we combine regulatory expertise and medical writing to help you develop PMCF plans and reports that are accurate, compliant, and aligned with your clinical and commercial objectives.
Need help with your PMCF documentation? Let’s talk.
Our experts are here to support you from first draft to final submission.
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