Post-Market Clinical Follow-up (PMCF) is a critical requirement under the EU Medical Device Regulation (MDR). It is not enough to write a generic PMCF plan and file it away. Notified Bodies now carefully review every aspect of PMCF activities to ensure manufacturers are generating meaningful clinical data, closing safety and performance gaps, and updating their technical documentation accordingly.
Yet many MedTech manufacturers still struggle. During audits and NB reviews, PMCF plans are often flagged as insufficient or unrealistic. Understanding the common pitfalls can help you design a strategy that not only meets MDR requirements but also supports your device’s long-term market success.
Here are the top five reasons PMCF plans fail under MDR (and how to avoid them).
1. The PMCF plan does not close clinical data gaps
The main objective of PMCF under MDR is to confirm the ongoing safety and performance of your device and to address any gaps identified in the Clinical Evaluation Report (CER). Too often, manufacturers create a “one-size-fits-all” PMCF plan without directly linking activities to these data gaps. This leads to plans that look nice on paper but do not withstand Notified Body scrutiny.
Best practice: Map your CER data gaps to specific PMCF activities. For example, if clinical evidence is limited for a particular patient subgroup, design a targeted PMCF study or registry that focuses on that group.
2. PMCF data collection methods are weak
Poorly designed data collection is one of the most common reasons PMCF plans fail. Many manufacturers rely only on surveys, but these often result in low response rates, incomplete answers, or biased data that do not meet MDR expectations.
Notified Bodies are looking for robust methodologies that provide statistically meaningful results and align with ISO 14155 standards where applicable.
Best practice: Consider a mix of methods such as registries, observational studies, user feedback programs, and structured surveys with clear follow-up strategies. Ensure that your PMCF activities are proportionate to the device risk class.
3. No integration with risk management and CER updates
PMCF is not a stand-alone exercise. Regulators expect to see a clear feedback loop where PMCF findings are integrated into the risk management file, CAPA system, Instructions for Use (IFU), and Clinical Evaluation Report. Plans that fail to explain how this integration will happen appear superficial and are often rejected.
Best practice: From the start, define how PMCF outcomes will update your CER and risk management documentation. This demonstrates a living process that evolves with real-world data.
4. Overly optimistic timelines and unrealistic scope
Notified Bodies know the effort and time required to run a clinical study, collect data, and analyze outcomes. A PMCF plan that promises quick turnaround without proper resourcing is a red flag.
For example, claiming to complete a multi-center PMCF study in three months may seem appealing internally, but NBs will recognize it as unrealistic.
Best practice: Build realistic timelines with interim milestones and acknowledge potential challenges such as patient recruitment or follow-up delays. Transparency in planning helps build NB trust.
5. Overly optimistic timelines and unrealistic scope
Even when data is collected, PMCF plans fail if the outcomes are not analyzed, reported, and acted upon. Many manufacturers stop at gathering feedback but never show how findings influenced clinical evaluation, risk files, or product updates.
NBs expect to see documented evidence that PMCF data has been reviewed and has led to corrective or preventive actions where necessary.
Best practice: Define from the beginning how reports will be generated, who will review them, and how the results will feed into your Post-Market Surveillance (PMS) system.
Why PMCF compliance matters under MDR
Failing to demonstrate a strong PMCF strategy can result in:
- Non-conformities raised during audits
- Delays in CE marking or re-certification
- Increased regulatory scrutiny for future submissions
- Risk to market access if clinical data does not support ongoing safety and performance
On the other hand, a well-structured PMCF program gives manufacturers valuable insights into device performance, strengthens the Clinical Evaluation, and builds confidence with regulators and customers.
Turning PMCF into a compliance strength
PMCF is one of the most challenging MDR requirements, but it can also be a strategic advantage when done right. By addressing data gaps, improving methodologies, integrating with risk management, and planning realistic timelines, you can transform PMCF from a regulatory hurdle into an asset for your device portfolio.
At Qserve, our CRO team specializes in designing and executing PMCF strategies that are audit-ready and MDR compliant. We combine clinical research expertise with regulatory depth, ensuring that your PMCF plan withstands Notified Body review.
If you want to ensure your PMCF plan won’t fail under MDR, get in touch with us today. Contact us to learn how we can help you.