If you are working with medical devices in the European Union, you may have come across the term PMCF, which stands for Post-Market Clinical Follow-up. But what does it really mean, and why is it important?
Under the Medical Device Regulation (EU) 2017/745 (MDR), PMCF is a continuous process of collecting and evaluating clinical data after a device has received CE marking and is being used in the real world. The goal is to confirm that the device remains safe and performs as intended throughout its entire lifecycle.
PMCF is part of the broader Post-Market Surveillance (PMS) system. While PMS includes all kinds of activities related to monitoring a device on the market, PMCF focuses specifically on clinical data. This includes gathering real-world evidence, identifying new risks or side effects, and confirming that the device continues to offer a favorable benefit-risk profile.
Examples of PMCF activities include follow-up clinical investigations, user surveys or questionnaires, patient registries, case reviews, literature screening, and the analysis of complaints, incidents, and feedback from healthcare professionals.
Manufacturers are required to include a PMCF plan in their PMS plan. This requirement is described in MDR Article 61 and Annex XIV Part B. The findings from PMCF activities must be analyzed and documented in a PMCF evaluation report. This report becomes part of the clinical evaluation and contributes to the technical documentation. If needed, the results may lead to updates in risk management documentation, the PMS plan, and the Summary of Safety and Clinical Performance (SSCP).
According to MDCG 2020-8 guidance, the PMCF process is not optional. It plays a key role in maintaining CE marking, demonstrating regulatory compliance, and most importantly, protecting patient safety.
A PMCF plan is designed to:
PMCF is more than a regulatory obligation. It is a valuable opportunity to strengthen your clinical evidence, support continuous improvement, and maintain trust in your device over time. By investing in effective PMCF, manufacturers can safeguard both compliance and patient outcomes.
Navigating PMCF requirements under MDR can be complex, but you don’t have to do it alone. At Qserve, we help medical device manufacturers design and implement effective PMCF strategies that are compliant, practical, and tailored to your device and risk profile. Whether you’re updating your clinical evaluation or preparing a PMCF plan from scratch, our experts are here to support you at every step.
Want to strengthen your clinical evidence and stay compliant under MDR?
Get in touch with our team to explore how we can support your PMCF activities with confidence.