Many MedTech manufacturers start by handling Post-Market Clinical Follow-up (PMCF) internally. On paper, this seems logical – your team knows the device best, and internal resources may appear more cost-effective. 

But when Notified Bodies (NBs) review these PMCF plans, they often flag serious gaps. Internal efforts can fall short not because teams lack dedication, but because PMCF under MDR requires a unique combination of clinical, regulatory, and methodological expertise that few in-house teams can fully cover. 

Here are the most common gaps we see and what’s missing from many internal PMCF efforts. 

1. Lack of robust methodology

Surveys or feedback forms are often chosen because they are easy to run in-house. Unfortunately, these methods frequently result in low response rates, incomplete datasets, or biased results. 

What’s missing: Clinical research expertise in designing methodologies that deliver reliable, audit-ready data. 

2. Weak alignment with the Clinical Evaluation Report (CER) 

Internal PMCF plans often fail to directly link activities to clinical data gaps identified in the CER. Without this connection, NBs see PMCF as superficial or irrelevant. 

What’s missing: Regulatory insight into how PMCF feeds back into CER updates and demonstrates continuous safety and performance. 

3. Poor integration with risk management and CAPA 

PMCF results must loop back into the risk management file and CAPA system. Many internal teams stop after collecting data, with little evidence of how outcomes affect product safety or updates. 

What’s missing: A systematic process to integrate PMCF findings into risk management, IFUs, and CAPAs. 

4. Unrealistic timelines and limited resources 

Running PMCF is resource-intensive. Internal teams often underestimate the time needed for patient recruitment, monitoring, or data analysis. Overly optimistic timelines are easy for NBs to spot. 

What’s missing: Realistic planning and dedicated clinical operations support. 

5. Documentation gaps and audit readiness

PMCF must stand up to Notified Body audits. Many in-house PMCF efforts produce results, but lack the clear documentation, traceability, and reporting needed to prove compliance. 

What’s missing: A quality management framework aligned with ISO 14155 and MDR documentation expectations. 

Why external expertise makes the difference 

PMCF is not just a regulatory checkbox – it is a structured process that requires clinical study design, regulatory compliance knowledge, and strong documentation practices. When handled internally, one of these areas is often missing, leaving manufacturers exposed during NB review. 

At Qserve CRO, we bring together clinical researchers, regulatory experts, and MedTech specialists to design and execute PMCF strategies that are: 

• Aligned with MDR and NB expectations 
• Linked to CERs and risk management files 
• Based on robust, realistic methodologies 
• Fully documented and audit-ready 

Ready to strengthen your PMCF? 

If your internal PMCF efforts are struggling to deliver results, you don’t have to face the challenge alone. Get in touch with Qserve CRO today and let our experts help you build a PMCF strategy that stands up to NB review and strengthens your compliance position. 

Contact us to learn how we can help you.